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PubMed1989

Antibiotic prophylaxis in colorectal surgery. Combined doxycycline-tinidazole vs. doxycycline alone.

Single-dose doxycycline was compared with single-dose doxycycline + tinidazole in regard to prevention of septic complications after colorectal surgery, taking into account the type and level of surgery--right or left hemicolectomy, rectal operations and others. The study was performed as a prospective double-blind trial, with randomization in blocks. In colorectal surgery as a whole the combination was found to be more effective than doxycycline alone. When the four surgical blocks were separately considered, however, the difference between the two regimens was found to be mainly due to rectal operations, following which the incidence of abdominal and of perineal wound infections was significantly lower with the combined regimen than with doxycycline alone. The subgroups composed of right-sided or left-sided hemicolectomy or other operations were too small to permit definite conclusions.

Adolescent↗
PubMed1995

Dual therapy with doxycycline and ketoprofen compared to doxycycline in the treatment of uncomplicated non-gonococcal urethritis.

The aim of this study was to compare a combination of doxycyline and ketoprofen, and doxycycline alone in treating non-gonococcal urethritis (NGU), with particular emphasis on reducing recurrent or persistent disease. Sixty-five men with first episode acute NGU were enrolled between November 1992 and November 1994. The men were randomly assigned to either the doxycycline plus ketoprofen group, group A (doxycycline 100 mg twice daily for 10 days plus ketoprofen 200 mg daily for 10 days, n = 34), or the doxycycline group, group B (100 mg twice daily for 10 days, n = 31). Out of the 65 patients studied, Chlamydia trachomatis was isolated from 9 patients (13.8%), Ureaplasma urealyticum from 6 patients (9.2%) and Mycoplasma hominis from 2 patients (3.1%). At 6 weeks in group A, 16 patients (47%) were cured, one patient had a recurrence (2.9%), and 4 patients had persistent infection (11.8%). Eleven patients defaulted follow-up (32.4%) and 2 patients were dropped from the trial. In contrast, for group B, 13 patients (42%) were cured, 5 patients (16%) had a recurrence, 2 patients (6.5%) had persistent infection and 3 patients (9.7%) were reinfected. Eight patients (25.8%) defaulted follow-up. At 12 weeks, for group A, 14 patients (41.2%) remained cured, one patient (2.9%) had a recurrence, 4 patients (11.8%) had persistent infection and one patient (2.9%) was reinfected. Twelve patients (35.3%) defaulted follow-up. For group B, 8 patients (25.8%) remained cured, 6 patients (19.4%) had recurrence, 2 patients (6.5%) had persistent infection and 5 patients (16.1%) were reinfected. Ten patients (32.2%) defaulted follow-up. There were no statistically significant differences between the two groups except for patients with recurrent NGU where the difference (1 versus 6 patients) was statistically significant (P = 0.019).

Anti-Bacterial Agents↗
PubMed2006

Efficacy of gentamicin plus doxycycline versus streptomycin plus doxycycline in the treatment of brucellosis in humans.

BACKGROUND: In the treatment of human brucellosis, antibiotic regimens containing an aminoglycoside are reportedly associated with fewer relapses. METHODS: This prospective, randomized study employed doxycycline (100 mg administered orally twice daily for 45 days) in combination with either streptomycin (1 g administered intramuscularly daily for 14 days; the DS regimen) or gentamicin (5 mg/kg per day administered intramuscularly for 7 days; the DG regimen). Efficacy of treatment was determined by rates of failure or relapse with a follow-up period of 1 year. RESULTS: Ninety-seven patients with a mean age (+/- standard deviation [SD]) of 33.74+/-15.47 years and 94 patients with the a mean age (+/-SD) of 36.2+/-14.14 years were treated with regimens DG and DS, respectively (P = .277). The clinical manifestations in both groups of patients were similar with the exception of sweating, which was more common in the DG group (P = .04). Three (3.2%) of the patients in the DS group and 3 (3.1%) of patients in the DG group experienced relapse (difference, 0.1%; 95% confidence interval [CI], -4% to 5%; P = 1.0). Overall, 7 (7.4%) of the patients in the DS group and 5 (5.2%) of the patients in the DG group experienced failure of therapy or relapse (difference, 2.2%; 95% CI, -4.5% to 8.9%; P = .563). The actuarial probability for relapse at 12 months after completion of therapy was 4.3% in the DS group and 2.1% in the DG group (difference, 2.2%; 95% CI, -2.8% to 7.2%). CONCLUSIONS: The combination of oral doxycycline for 45 days plus intramuscular gentamicin for 7 days is equally as effective as traditional therapy using doxycycline for 45 days plus streptomycin for 14 days.

Adolescent↗
PubMed2005

Open-label randomized trial of oral trimethoprim-sulfamethoxazole, doxycycline, and chloramphenicol compared with trimethoprim-sulfamethoxazole and doxycycline for maintenance therapy of melioidosis.

Melioidosis (infection caused by Burkholderia pseudomallei) requires a prolonged course of oral antibiotics following initial intravenous therapy to reduce the risk of relapse after cessation of treatment. The current recommendation is a four-drug regimen (trimethoprim [TMP], sulfamethoxazole [SMX], doxycycline, and chloramphenicol) and a total treatment time of 12 to 20 weeks. Drug side effects are common; the aim of this study was to compare the efficacy and tolerance of the four-drug regimen with a three-drug regimen (TMP-SMX and doxycycline). An open-label, randomized trial was conducted in northeast Thailand. A total of 180 adult Thai patients were enrolled, of which 91 were allocated to the four-drug regimen and 89 to the three-drug regimen. The trial was terminated early due to poor drug tolerance, particularly of the four-drug regimen. The culture-confirmed relapse rates at 1 year were 6.6% and 5.6% for the four- and three-drug regimens, respectively (P = 0.79). The three-drug regimen was better tolerated than the four-drug regimen; 36% of patients receiving four drugs and 19% of patients receiving three drugs required a switch in therapy due to side effects (P = 0.01). The duration of oral therapy was significantly associated with relapse; after adjustment for confounders, patients receiving less than 12 weeks of oral therapy had a 5.7-fold increase of relapse or death. A combination of TMP-SMX and doxycycline is as effective as and better tolerated than the conventional four-drug regimen for the oral treatment phase of melioidosis.

Adolescent↗
PubMed2004

Comparative bioavailability study of doxycycline hyclate (equivalent to 100 mg doxycycline) capsules (doxycin vs vibramycin) for bioequivalence evaluation in healthy adult volunteers.

This investigation was carried out to evaluate the bioavailability of a new capsule formulation of doxycycline (100 mg), doxycin, relative to the reference product, vibramycin (100 mg) capsules. The bioavailability was carried out in 24 healthy male volunteers who received a single dose (100 mg) of the test (A) and the reference (B) products after an overnight fast of at least 10 hours on 2 treatment days. The treatment periods were separated by a 2-week washout period. A randomized, balanced 2-way cross-over design was used. After dosing, serial blood samples were collected for a period of 48 hours. Plasma concentrations of doxycycline were analyzed by a sensitive and validated high-performance liquid chromatography assay. The pharmacokinetic parameters for doxycycline were determined using standard noncompartmental methods. The parameters AUC(0-t), AUC(0-infinity), Cmax, K(el), t(1/2) and Cmax/AUC(0-infinity) were analyzed statistically using log-transformed data. The time to maximum concentration (tmax) was analyzed using raw data. The parametric 90% confidence intervals of the mean values of the pharmacokinetic parameters: AUC(0-t), AUC(0-infinity), Cmax and Cmax/AUC(0-infinity) were within the range 80-125% which is acceptable for bioequivalence (using log-transformed data). The calculated 90% confidence intervals based on the ANOVA analysis of the mean test/reference ratios of AUC(0-t), AUC(0-infinity), Cmax and Cmax/AUC(0-infinity) were 95.98-109.56%, 92.21 to 107.66%, 93.90-112.56%, and 96.0 to 106.91% respectively. The test formulation was found bioequivalent to the reference formulation with regard to AUC(0-t), AUC(0-infinity), Cmax and Cmax/AUC(0-infinity) by the Schuirmann's two 1-sided t-tests. Therefore, the 2 formulations were considered to be bioequivalent.

Administration, Oral↗
PubMed1992

Effect of doxycycline on the generation of reactive oxygen species: a possible mechanism of action of acne therapy with doxycycline.

On the basis of a recent report that minocycline is effective in the treatment of acne inflammation by acting directly as an antioxidant on infiltrating neutrophils, we investigated whether doxycycline might also be capable of reducing the generation of reactive oxygen species, using human neutrophils and a cell-free, xanthine-xanthine oxidase system. The species investigated are superoxide radical anion (O2-), hydrogen peroxide (H2O2) and hydroxyl radical (OH.). Doxycycline significantly reduced the levels of O2-, H2O2 and OH. generated by both systems. Our results seem to suggest that the clinical effectiveness of doxycycline in the treatment of acne inflammation is due partly to its antioxidant effect on neutrophils.

Doxycycline↗
PubMed1980

Tinidazole and doxycycline compared to doxycycline alone as prophylactic antimicrobial agents in elective colorectal surgery.

Forty-two patients admitted for elective colorectal surgery were given tinidazole and doxycycline or doxycycline alone as prophylactic antimicrobials in a double-blind study. There was altogether one abdominal wound infection (2.4%), and one patient developed a perineal fistula three months after the operation. No significant difference in postoperative infections between the two groups could be demonstrated. It is concluded that doxycycline seems effective in reducing wound sepsis after operations on the large intestine and that additional administration of tinidazole will yield little in prophylaxis.

Aged↗
PubMed1987

Single-dose chemoprophylaxis in elective colorectal surgery. A comparison between doxycycline plus metronidazole and doxycycline.

In a prospective, randomized double-blind study either 400 mg of doxycycline + 1500 mg of metronidazole (D + M) or 400 mg of doxycycline (D) alone were given intravenously as a single preoperative dose to patients admitted for elective colorectal surgery. A comparison of the rate of postoperative septic complications was made. After excluding drop-out patients, 261 patients remained for evaluation. In 135 patients with D + M treatment there were four postoperative septic complications (3.0%). In 126 patients with D treatment 20 septic complications related to the surgical procedure occurred (15.9%). The difference is highly significant (p less than 0.005). Most postoperative infections were superficial wound infections (14 of 24 patients), and the mean hospital stay in the two treatment groups was equal. Bacteriologic studies showed a highly significant reduction in anaerobes in cultures from perioperative intra-abdominal fluid in the D + M treatment group. The study has thus showed that the addition of metronidazole, an efficient agent against anaerobic bacteria, to an antimicrobial agent against aerobic bacteria significantly reduces postoperative septic complications in elective colorectal surgery.

Adolescent↗
PubMedDate not supplied

Comparison of cefotetan plus doxycycline with cefoxitin plus doxycycline in the inpatient treatment of acute salpingitis.

Pelvic inflammatory disease (PID), one of the major sequelae of the current epidemic of sexually transmitted diseases, has been shown to be a polymicrobial infection. This study compares the efficacy and safety of two broad-spectrum combination drug regimens, cefotetan with doxycycline and cefoxitin with doxycycline, in the treatment of PID. A total of 108 patients with acute salpingitis were hospitalized and randomized into two treatment groups: cefotetan/doxycycline (N = 54) and cefoxitin/doxycycline (N = 54). Before antibiotic administration, Chlamydia trachomatis was identified in 17 (16%) of the patients, Neisseria gonorrhoeae from 72 (67%), and anaerobic and aerobic bacteria were identified from the endometrial cultures of 86 (80%). There were seven tubo-ovarian abscesses (TOAs) that were diagnosed in the cefotetan group, and six in the cefoxitin group. Clinical cure was achieved in 51 of 54 (94%) patients in each group. Of the six patients whose treatment failed, all had positive cultures for N. gonorrhoeae and facultative/anaerobic bacteria, whereas none had C. trachomatis. Two patients from each study arm whose treatment failed were diagnosed with TOAs and responded subsequently to clindamycin plus an aminoglycoside. Cultures that were obtained after the completion of inpatient treatment showed the eradication of C. trachomatis and N. gonorrhoeae in all patients. Also, both regimens were effective in reducing aerobic and anaerobic pathogens. Finally, both regimens were well tolerated, with few side-effects.

Acute Disease↗
PubMed1984

Bioavailability of doxycycline monohydrate. A comparison with equivalent doses of doxycycline hydrochloride.

Two derivatives of doxycycline, the monohydrate-free base and the hydrochloride salt were given orally to 12 volunteers in a crossover study. There was no difference in absorption and bioavailability between the two preparations. Secondary plasma peaks indicating reabsorption were noticed for both derivatives. Doxycycline monohydrate, proven to have a lower risk of inducing esophageal lesions, is a good alternative to the hydrochloride salt in oral treatment.

Absorption↗
PubMed1991

Doxycycline tolerance study. Incidence of nausea after doxycycline administration to healthy volunteers: a comparison of 2 formulations (Doryx' vs Vibramycin').

In a randomised, double-blind, 3-way cross-over trial, the incidence of nausea associated with 2 doxycycline 100 mg formulations (Doryx' and Vibramycin') were compared. The original study cohort comprised 103 healthy male volunteers, with 97 subjects completing the trial. Subjects were randomly allocated to 1 of 3 treatment sequences and received a single dose of Doryx', Vibramycin' or placebo, with a 7-day washout prior to cross-over. At half-hourly intervals, from 0 to 2 h post-dose, subjects completed questionnaires to indicate if they felt nauseous. Data were analysed according to a log-linear method for the analysis of cross-over trials with categorical responses. Seventeen, 29 and 11 subjects experienced nausea with Doryx', Vibramycin' and placebo, respectively. A significantly greater number of volunteers indicated a positive response with Vibramycin' vs Doryx' and vs placebo; the positive response frequency was not significantly different for the Doryx' vs the placebo regimen. Treatment sequence had no significant effect on response, although a marked first-dose effect was noted; the first (vs the second and vs the third) regimen was 1.5-2 times more likely to induce a positive response.

Adult↗
PubMed1984

Doxycycline prophylaxis of travelers' diarrhea in Honduras, an area where resistance to doxycycline is common among enterotoxigenic Escherichia coli.

Daily doxycycline (DX), known to be effective prophylaxis against travelers' diarrhea (TD) in areas of the world where enterotoxigenic Escherichia coli (ETEC) are sensitive to the drug, has not been extensively studied in geographic areas where antibiotic resistance is common. Therefore we studied 44 U.S. Peace Corps Volunteers during their first 5 weeks in Honduras, which is such an area. During the first 3 weeks, volunteers took daily either 100 mg DX or placebo (PL) in a double-blind, randomized fashion. All 22 taking PL developed TD during the first 3 weeks, compared to 7 of 22 (32%) taking DX (P less than 0.001; 68% protection). ETEC were isolated from 39% of episodes of TD. From the PL group, ETEC from 7 of 13 stool samples (54%) were resistant to DX, whereas from the DX group, ETEC from 10 of 11 stool samples were resistant (P less than 0.05). TD that developed in persons taking DX was also found to be less severe, as judged by length of illness (P less than 0.01) and frequency of stools (P less than 0.05). This study demonstrates that DX 1) significantly prevents TD even in areas where antibiotic resistance is common, although it does not prevent TD caused by docycycline -resistant ETEC, and 2) significantly diminishes the severity of illness.

Adult↗
PubMed1990

Bioavailability of doxycycline from dissolved doxycycline hydrochloride tablets--comparison to solid form hydrochloride tablets and dissolved monohydrate tablets.

Doxycycline (DC) is used either as solid form hydrochloride capsules, or as monohydrate tablets, which may be taken either as solid form tablets or dissolved in water. In this single dose (150 mg), crossover study on 15 healthy volunteers, the pharmacokinetic properties of DC from hydrochloride tablets taken either in dissolved or in solid form were compared with those observed after taking dissolved DC as a monohydrate tablet. The results of this study show that DC is absorbed rapidly (tmax 3.3-3.8 h) and with equal bioavailability (AUC values 52.9-58.5 mg/l x h) from both hydrochloride and monohydrate tablets. It can be concluded that taking the DC hydrochloride tablets in dissolved form does not affect the pharmacokinetics of DC, moreover the bioavailability of DC is comparable to that achieved after taking DC monohydrate tablets in dissolved form.

Biological Availability↗