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PubMed2006

Factors related to response to intermittent treatment of Mycobacterium avium complex lung disease.

RATIONALE: Mycobacterium avium complex pulmonary disease (MAC-PD) is associated with substantial morbidity, and standard daily multidrug therapy is difficult to tolerate. OBJECTIVES: To characterize response to a three-times-weekly (TIW) regimen of clarithromycin, ethambutol, and rifampin. METHODS: A 1-yr prospective noncomparative trial of TIW treatment was conducted during 2000-2003 in 17 U.S. cities. Participants were 91 HIV-negative adults, diagnosed with moderate to severe MAC-PD, who originally participated in a trial of an inhaled IFN-gamma treatment. Improvement in sputum culture, high-resolution computed tomography (HRCT), and symptoms were assessed. RESULTS: Treatment response rates (and median response times) were 44% (2 mo or longer) for culture, 60% (5.5-11.5 mo) for HRCT, and 53% (8.5 mo) for symptoms. Having noncavitary, compared with cavitary, disease increased culture response by 4.0 times (95% confidence interval [CI], 1.7-9.2) and HRCT response by 4.9 times (95% CI, 1.9-13.0). Culture response was 1.5 times (95% CI, 1.1-2.2) higher for older subjects and 2.2 times (95% CI, 1.0-4.7) higher for previously untreated subjects. Being smear-negative increased culture response by 2.3 times (95% CI, 1.1-5.2) but decreased HRCT response by 4.4 times (95% CI, 1.7-11.5). Increasing ethambutol use by 5 mo increased culture response by 1.5 times (95% CI, 1.0-2.1) but decreased symptom response. Not having chronic obstructive pulmonary disease, bronchiectasis, or poor lung function increased symptom response by 1.9 to 3.9 times. CONCLUSIONS: TIW therapy was less effective for MAC-PD patients with cavitary disease and a history of chronic obstructive pulmonary disease, bronchiectasis, or previous treatment for MAC-PD. Further research is needed to study the long-term outcomes of TIW treatment.

Aged↗
PubMed2000

A comparison of the E-test and proportion methods for susceptibility testing of Mycobacterium tuberculosis.

The aim of this study was to investigate the correlation between three antibiotic susceptibility methods, the proportion method on Löwenstein Jensen medium (LJ medium), the proportion method on Middlebrook 7H11 agar (7H11 agar), and the E-test for Mycobacterium tuberculosis. Fifty M. tuberculosis isolates were tested in vitro against isoniazid, rifampicin, streptomycin, and ethambutol according to the E-test, the proportion methods on 7H11 agar and LJ medium and then compared with a reference test which was the proportion method on 7H11 agar. The correlations between proportion method on 7H11 agar and proportion method on LJ medium for isoniazid, rifampicin, streptomycin, and ethambutol were 93.9%, 85.1%, 85.4% and 78.7% respectively. The correlations between the proportion method on 7H11 agar and the E-test were 83.1%, 78.8%, 84.7% and 80.5% respectively. There were no significant differences observed between the E-test and LJ medium compared to 7H11 agar. The average times to obtain susceptibility test results were 7 and 21 days for the E-test and agar proportion methods, respectively. The E-test may be suitable for replacing the proportion methods (7H11 agar and LJ medium) in routine practice due to its fast and easy application.

Antitubercular Agents↗
PubMed2000

Symptomatic and health status outcomes in the Canadian randomized MAC treatment trial (CTN010). Canadian HIV Trials Network Protocol 010 Study Group.

Our objective was to compare the effect of 2 regimens for treatment of Mycobacterium avium complex (MAC) bacteraemia in an HIV-positive population on symptoms and health status outcomes using a substudy of an open-label randomized controlled trial. The study was conducted in 24 hospital-based human immunodeficiency virus (HIV) clinics in 16 Canadian cities. Patients had HIV infection and MAC bacteraemia and were given either rifampin 600 mg, ethambutol 15 mg/kg daily, clofazimine 100 mg daily and ciprofloxacin 750 mg twice daily (4-drug arm) or rifabutin 600 mg daily (amended to 300 mg daily in mid-trial), ethambutol 15 mg/kg daily and clarithromycin 1000 mg twice daily (3-drug arm). The primary health status outcome was the change on the 8-item symptom subscale of the Medical Outcome Study (MOS)-HIV Health Survey adapted for MAC. Changes on other MOS-HIV subscales and on the Karnofsky score were also evaluated. Patients on the 3-drug arm had better outcomes on the MOS-HIV symptom subscale at 16 weeks (P=0.06), with statistically significant differences restricted to night sweats and fever and chills (P < 0.001). The proportion of patients improving on the symptom subscale relative to baseline was 55% on the 3-drug arm and 40% on the 4-drug arm. Patients on the 3-drug arm also had better Karnofsky score at 16 weeks (P < 0.001) and better outcomes on the social function, mental health, energy/fatigue, health distress and cognitive function subscales of the MOS-HIV. The 3-drug arm is superior to the 4-drug arm in terms of impact on MAC-associated symptoms, functional status and other aspects of health status.

AIDS-Related Opportunistic Infections↗
PubMed2006

Evaluation of rapid alternative methods for drug susceptibility testing in clinical isolates of Mycobacterium tuberculosis.

A study was carried out to compare the performance of a commercial method (MGIT) and four inexpensive drug susceptibility methods: nitrate reductase assay (NRA), microscopic observation drug susceptibility (MODS) assay, MTT test, and broth microdilution method (BMM). A total of 64 clinical isolates of Mycobacterium tuberculosis were studied. The Lowenstein-Jensen proportion method (PM) was used as gold standard. MGIT NRA, MODS, and MTT results were available on an average of less than 10 days, whereas BMM results could be reported in about 20 days. Most of the evaluated tests showed excellent performance for isoniazid and rifampicin, with sensitivity and specificity values > 90%. With most of the assays, sensitivity for ethambutol was low (62-87%) whereas for streptomycin, sensitivity values ranged from 84 to 100%; NRA-discrepancies were associated with cultures with a low proportion of EMB-resistant organisms while most discrepancies with quantitative tests (MMT and BMM) were seen with isolates whose minimal inhibitory concentrations fell close the cutoff MGIT is reliable but still expensive. NRA is the most inexpensive and easiest method to perform without changing the organization of the routine PM laboratory performance. While MODS, MTT, and BMM, have the disadvantage from the point of view of biosafety, they offer the possibility of detecting partial resistant strains. This study shows a very good level of agreement of the four low-cost methods compared to the PM for rapid detection of isoniazid, rifampicin and streptomycin resistance (Kappa values > 0.8); more standardization is needed for ethambutol.

Antitubercular Agents↗
PubMed1977

Penetration of antitubercular drugs in clinical osteoarticular tubercular lesions.

In 79 consecutive cases of skeletal tuberculosis the concentration of streptomycin and ethambutol was analysed. The material for analysis was obtained from the diseased joints of 14 patients and from cold abscesses from spinal or osseous lesions in 65 patients. The concentration of the drugs in the serum and in the tuberculous material was measured 3 hours after the systemic administration of the drugs in therapeutic doses. The concentration was expressed as microgram per ml of the tuberculous material and the data were subjected to statistical analysis. Streptomycin and ethambutol penetrated freely into the tuberculous joints; their concentration in the cold abscesses, however, was half to one third of the concentration in the serum. There was a wide range of concentrations; however, in the tuberculous joints as well as in the cold abscesses the concentrations were much higher than those considered to have an inhibitory effect on mycobacterium tuberculosis in clinical material.

Adolescent↗
PubMed1997

[Experimental study on the antituberculous activity of ofloxacins].

OBJECTIVE: To compare the antituberculous activities of ofloxacins (OFLX) made by different pharmaceutical companies. METHODS: The minimal inhibitory concentrations (MIC) of OFLX were determined by two-fold dilution method. The efficacy of OFLX was compared in terms of median survival time (ST50) against M. tuberculosis infection in mice. RESULTS: In vitro the activities against M. tuberculosis (H37Rv), M. bovis (Ravenel) and M. Phlei products showed similar degree. The MICs of OFLX were 0.5-1.0 microgram/ml in modified Sauton medium and 1.0 microgram/ml in modified Lowenstin-Jensen medium. OFLX was more active than ethambutol (MIC 4-8 micrograms/ml, 2.0 micrograms/ml, respectively) against M. tuberculosis in the same media. OFLX from domestic or foreign drug companies showed similar results for treating M. tuberculosis infection in mice and all were significantly effective. The efficacy of OFLX at the dose of 4 mg per mouse was found close to that of ethambutol (EMB) at the dose of 2 mg per mouse. The efficacy of OFLX at the dose of 2 mg per mouse close to EMB at the dose of 1 mg per mouse and thiacetazone at the dose of 2 mg per mouse. CONCLUSIONS: In vitro and in vivo, the activities of OFLX from different sources against M. tuberculosis are about the same.

Animals↗
PubMed1976

Some aspects of tuberculous meningitis in Surabaya.

Eighty tuberculous meningitis patients who were seen in the neurological clinics in Surabaya between the January 1971 and January 1975 were asked to cooperate in a double blind clinical trial. One group was given isoniazid, streptomycin and p-aminosalicylic acid, the other group was given isioniazid, rifampicin, ethambutol and a protease. The outcome after the treatment with isoniazid, rifampicin and ethambutol was significantly better than that with isoniazed, streptomycin and p-aminosalicylic acid. The clinical and laboratory symptoms and signs are reviewed in detail.

Adolescent↗
PubMed1999

The colorimetric analysis of anti-tuberculosis fixed-dose combination tablets and capsules.

SETTING: The perceived need to demonstrate whether or not the actual amounts of rifampicin, isoniazid and pyrazinamide in fixed-dose combination tablets or capsules correspond to their stated drug contents. OBJECTIVE: To adapt specific, robust and simple colorimetric methods that have been previously applied to measuring plasma and urinary rifampicin, isoniazid, pyrazinamide and ethambutol concentrations to estimate tablet and capsule drug contents. DESIGN: The methods were applied to the analysis of 14 commercially manufactured fixed-dose combinations: two capsule and three tablet formulations containing rifampicin and isoniazid; seven tablet formulations containing rifampicin, isoniazid and pyrazinamide; and two tablet formulations containing rifampicin, isoniazid, pyrazinamide and ethambutol. RESULTS: All the combined formulations contained near to their stated drug contents. Replicate analyses confirmed the excellent precision of the drug analyses. CONCLUSION: Such methods are not only rapid to perform but should be practical in many Third World situations with relatively modest laboratory facilities.

Antitubercular Agents↗
PubMed2000

Trends in antituberculosis drug resistance in Karonga District, Malawi, 1986-1998.

SETTING: Karonga District, Malawi. OBJECTIVES: To examine long term trends in initial and acquired resistance to antituberculosis drugs in a rural area of Africa. DESIGN: Monitoring of all patients with culture-confirmed tuberculosis 1986-1998. RESULTS: Initial drug resistance results were available for 1121 patients. The proportion resistant to any of the first line drugs (streptomycin, isoniazid, rifampicin or ethambutol) was 9.6%, and to isoniazid 7.2%. Initial resistance to at least isoniazid and rifampicin (multidrug resistance) was seen in only six patients. No initial resistance to ethambutol was found. There was no significant change in initial drug resistance over time. Overall, 22/120 (18%) patients with previous treatment were resistant to at least one drug; only one had multidrug resistance. Acquired resistance decreased over the period of the study. There were no associations between age, sex or human immunodeficiency virus (HIV) status and initial or acquired drug resistance. CONCLUSIONS: Changes in acquired resistance may reflect the recent performance of a control programme more quickly than those in initial resistance. It is encouraging that acquired resistance decreased and levels of multidrug resistance were low despite more than a decade of use of rifampicin. The lack of association between HIV and drug resistance confirms findings elsewhere in Africa.

Adult↗
PubMed2000

[Early anterolateral surgery for tuberculosis of the lower cervical spine with neurological complications in adult. Our experience in Gabon].

OBJECTIVE: To report our therapeutic experience with tuberculosis of the lower cervical spine with neurological complications in 9 adults in Gabon. PATIENTS AND METHODS: A retrospective study of these 9 adults treated for progressive Pott's tetraplegia or paraplegia from 1982 to 1998 was conducted. The medical treatment consisted of the early administration in the first 3 patients of rifampin, isoniazid and ethambutol for 18 months; and, in the remaining 6 patients, of rifampin, isoniazid, ethambutol and pyrazinamide for 6 months. This medical treatment was systematically started 3 weeks before surgery in 7 patients, once the disease had been diagnosed radiologically. Two patients with an acute onset of paraplegia underwent surgery on an emergency basis. The standard anterior approach was used: debridement was done in 3 cases, to establish the diagnosis; 6 patients underwent radical surgery for severe neurological deficit and spinal instability. Average follow-up time was 40.6 months. RESULTS: Three patients were found to be functionally and neurologically normal at follow-up examinations. Eight of the nine patients recovered sufficiently to walk unaided. One patient was able to get about on crutches. After 3-4 months, a satisfactory consolidation was already observed, with reduction of kyphosis in 4 cases. All patients were considered medically cured by the Antituberculous Center. CONCLUSION: Early radical surgery, as primary procedure, in conjunction with a six-month chemotherapeutic regimen (four drugs) seems to be adequate for the management of tuberculosis of the lower cervical spine with neurological complications and spinal instability, in our setting.

Adult↗
PubMed2002

Study of drug resistance in previously treated tuberculosis patients in Gujarat, India.

SETTING: Department of Tuberculosis and Chest Diseases and State Tuberculosis Diagnosis and Training Centre (STDTC), a DOTS centre in Ahmedabad, Gujarat State, India. The study was carried out by retrospectively reviewing patient data between January 2000 and August 2001. OBJECTIVE: To evaluate the pattern of drug resistance among previously treated tuberculosis patients who remained symptomatic or smear-positive despite receiving anti-tuberculosis drugs under DOTS for a minimum of 5 months. DESIGN: A total of 1472 pulmonary tuberculosis patients who had taken anti-tuberculosis treatment were evaluated retrospectively with respect to their drug resistance pattern by sputum culture for acid-fast bacilli (AFB) and sensitivity testing with isoniazid, rifampicin, streptomycin and ethambutol (E). RESULT: Of the 1472 patients evaluated, 804 (54.6%) were treatment failure cases and 668 (45.4%) were relapse cases; 822 patients (373 failure and 449 relapse) were culture-positive. Of these 822 patients, 482 (58.64%, 261 failure and 221 relapse) were resistant to one or more drugs. Resistance to one drug was observed in 86 patients (10.46%), to two drugs in 149 (18.13%), to three drugs in 122 (14.84%) and to four drugs in 125 (15.21%). Single drug resistance was most commonly seen with isoniazid (62 patients, 7.5%), followed by streptomycin (12 patients, 1.4%), rifampicin (eight patients, 0.97%) and ethambutol (four patients, 0.4%). Resistance to isoniazid plus rifampicin alone was seen in 76 patients (9.2%). CONCLUSION: Drug resistance is a major problem in the treatment of pulmonary tuberculosis. Detection of drug resistance patterns and treatment with second-line anti-tuberculosis drugs in appropriate regimens are necessary in the treatment of failure and relapse cases in order to reduce the emergence of multidrug-resistant tuberculosis.

Antibiotics, Antitubercular↗
PubMed2003

Pharmaceutical formulation of a fixed-dose anti-tuberculosis combination.

SETTING: Department of Pharmacy and Pharmacology, University of the Witwatersrand. Despite the availability of highly effective treatment regimens for tuberculosis (TB), the cure rate still remains relatively low. This may be attributed to the high incidence of patient non-compliance, which subsequently leads to the emergence of multidrug-resistant TB (MDR-TB). To avoid the problem of further creation and propagation of MDR-TB, it may be proposed that patients should be given fixed-dose combinations of anti-tuberculosis drugs whenever self-administration is permitted. OBJECTIVE: To optimise an anti-tuberculosis extemporaneous powder formulation for suspension in order to develop a fixed combination of rifampicin, isoniazid, pyrazinamide and ethambutol hydrochloride as a powder to be reconstituted with water by the patient prior to administration. METHODS: Different suspending agents were evaluated for their influence on powder flow properties, and sediment volume on the powder blends. Sodium starch glycolate was selected as the suspending agent because of its favourable powder flow properties and sediment volume produced. The dissolution characteristics of the extemporaneous powder for suspension were also compared to the dissolution profiles of commercially available anti-tuberculosis tablet dosage forms. RESULTS: The powder for suspension for rifampicin, isoniazid, pyrazinamide and ethambutol hydrochloride all compared favourably to the dissolution rate from the commercially available tablet dosage forms.

Administration, Oral↗
PubMed1992

The use of antimycobacterial agents in Crohn's disease.

Seventy-five years ago, a Scottish surgeon, Dalziel, clearly described Crohn's disease (CD) and suggested that it might be caused by a mycobacteria. However, mycobacteria were not isolated from CD tissue until 1978 and 1984. Since then several investigators, using sophisticated polymerase chain reaction (PCR) techniques, found Mycobacterium paratuberculosis sequences in cultures of Crohn's disease tissue in approximately two thirds of patients. Because of a possible mycobacterial etiology, Rutgeerts et al. (J Clin Gastroenterol 1992;15:24-8) treated resected ileocolonic CD patients who had early evidence of recurrence with ethambutol and rifabutin. Patients were followed by colonoscopy to observe changes in the intestinal lesions, but no improvement was noted. Rutgeerts et al. concluded that antimycobacterial therapy did not affect the course of CD. Failure of these antibiotics does not necessarily negate the mycobacterial theory of CD, however. The study population of Rutgeerts et al. was too small, and the treatment period too short. Furthermore, ethambutol shows little or no activity against the proposed Crohn's organism, Mycobacterium paratuberculosis; use of only one active agent (rifabutin) can lead to drug resistance and failure of antibiotic therapy. We hope that Rutgeerts et al. will continue these important studies, but with a more active combination of antimycobacterial drugs for a longer time.

Antitubercular Agents↗
PubMed2004

[Pulmonary Mycobacterium fortuitum infection with multiple nodular shadows in a healthy man].

We report a case of pulmonary Mycobacterium fortuitum infection with multiple nodular shadows. A 52 year-old male was admitted complaining of fever and chest abnormal shadows. He didn't have pulmonary or systemic underlying diseases. Chest radiograph and computed tomography scan showed multiple nodular shadows in the both lung fields. Isoniazid, rifampicin and ethambutol were administered based on the presumptive diagnosis of tuberculosis. Cultures of the sputum and bronchial washing fluid were repeatedly positive for M. fortuitum, and the case was diagnosed as pulmonary M. fortuitum infection. Although the in vitro susceptibility was resistant to isoniazid, rifampicin and ethambutol, abnormal shadows on the X-ray showed improvement by the combined use of INH, RFP and EB. There are no signs of recurrence after completion of the treatment for 12 months.

Antitubercular Agents↗
PubMed1992

Six-months versus nine-months chemotherapy for tuberculosis of lymph nodes: preliminary results. British Thoracic Society Research Committee.

One-hundred and ninety-nine patients with peripheral lymph node tuberculosis were randomized to treatment with either E2H9R9, Z2H9R9 or Z2H6R6 regimens (E, ethambutol; H, isoniazid; R, rifampicin; Z, pyrazinamide; numbers denote duration of therapy in months). One-hundred and thirty-three patients were diagnosed by aspiration/biopsy leaving residual nodes, 44 were diagnosed after excision of the palpable nodes and 22 were diagnosed on clinical grounds supported by a strongly positive tuberculin test. Treatment was completed as planned by 157 patients. Eight patients required aspirations after commencing chemotherapy, seven on ethambutol and one on pyrazinamide (P = 0.005). There was no statistically significant difference between the regimens in speed of resolution of nodes, or in the percentage with residual nodes at the end of treatment, or in the numbers developing fluctuation or sinuses. Follow-up to 30 months from commencement of treatment continues in order to establish relapse rates for the regimens.

Adolescent↗
PubMed2004

Evaluation of modified short course chemotherapy in active pulmonary tuberculosis patients with human immunodeficiency virus infection in University College Hospital, Ibadan, Nigeria--a preliminary report.

Over the period, 1st October 1999 to 30th April 2002 a clinical trial of the modified short-course chemotherapy (SCC) in newly diagnosed cases of pulmonary tuberculosis with human immunodeficiency virus (HIV) infection in Ibadan, Nigeria was carried out. The modified SCC used was adopted by World Health Organisation (WHO)/International Union against Tuberculosis and Lung Diseases (IUALTD) for developing countries and also by the Nigerian National Tuberculosis and Leprosy Control Programmed (NTLCP). The regimen used consisted of ethambutol (E), isoniazid (H), rifampicin (R) and pyrazinamide (Z) in the intensive phase of 2 months. The continuation phase was 6 months of ethambutol (E) and isoniazid(H), i.e. 2EHRZ/6EH. Sputum conversion was 90% at the second month of treatment and there was no bacteriological relapse after 18 months of follow-up. Side effects were few and consisted mainly of acne vulgaris in 20 (22.5%) of 89 patients during the continuation phase. It is concluded that this modified 8-month chemotherapy regimen adopted by NTLCP is efficacious in treatment of smear positive pulmonary tuberculosis (PTB) patients with background HIV infection.

Acne Vulgaris↗
PubMed1992

Resistance to antituberculosis drugs in treated patients in Lagos, Nigeria.

The extent and pattern of drug resistance among previously treated tuberculosis patients was investigated. Ninety-six patients with a total treatment duration of between 6 and 18 months and still smear and culture positive were examined. Treatment was either continuous or in intermittent blocks. Drug susceptibility tests on strains of tubercle bacilli isolated from the patients were performed against isoniazid, streptomycin, p-aminosalicylic acid, ethambutol and rifampicin by the proportion method using LJ medium without potato starch. A total of 56% of the strains were resistant to one or more of the drugs tested. Resistance to isoniazid (38%) and streptomycin (29%) was most common. A significant finding in the study was the low level of resistance to rifampicin (2%) and ethambutol (3%). A relationship between the incidence of drug resistance and the nature and duration of previous treatment appeared likely since susceptible strains were isolated more often from patients with continuous treatment than from patients on intermittent blocks of long-course regimens. It is therefore suggested that the introduction of better supervision of drug taking and the adoption of continuous short-course regimens on a nationwide level will contribute immensely towards the reduction of the drug resistance problems in Nigeria as well as in other developing countries.

Adolescent↗
PubMed1992

[Pulmonary infection caused by Mycobacterium gordonae (M. gordonae) in a healthy middle-aged male].

A 51-year-old man was admitted to our hospital in July 1989 because of an abnormality in his chest radiograph. On his yearly health check-up, an abnormality of his chest radiography was first noted in June 1988. At that time, examinations including bronchoscopy were performed but no specific diagnosis was made. On admission, his chest radiograph revealed new infiltrates at the apex of the right lung which were not present in June 1988. Three out of 5 consecutive sputum specimens after admission produced a pure growth of 100 colonies to 1+ of acid-fast bacilli (AFB). This AFB was scotochromogenic, and hydrolysis of Tween 80 at 5 days was positive. It did not reduce nitrate, and niacin test was negative. It was sensitive to ethambutol at a concentration of 5 micrograms/ml, and was not tolerant to 0.2% picric acid. We thus identified this AFB to be M. gordonae. The patient was treated with rifampicin (450 mg/day), isoniazid (400 mg/day), and ethambutol (1000 mg/day) for 9 months. After 2 months of treatment the sputum cultures became negative, and the chest radiograph showed improvement of the infiltrates. M. gordonae is considered to be one of the least pathogenic AFB to man. Most recent reports of M. gordonae infection have been in immunocompromized hosts or patients with a history of pulmonary tuberculosis. The present case is a very rare example of this organism affecting a healthy male, and thus yields new information on the pathogenesis of M. gordonae in man.

Drug Therapy, Combination↗