Long-term efficacy of pertussis vaccines in Italy. PROPER Study Working Group.
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Child, Preschool↗
Biomedical subjects
P Mastrantonio
Publications and source records attributed to P Mastrantonio.
Pattern of bacterial meningitis in Italy, 1994.
During 1994, 603 cases of bacterial meningitis were reported in Italy. Seventy-five percent of cases with determined etiology was due to three agents: Neisseria meningitidis (33.4%), Streptococcus pneumoniae (23.4%) and Haemophilus influenzae (18.6%). The majority of cases due to N. meningitidis and H. influenzae occurred in subjects below five years of age (35.7% and 84.8%, respectively) while S. pneumoniae accounted for 52.8% of meningitis cases in subjects older than 44 year of age. The estimated incidence of N. meningitidis on the national population in 1994 was 0.27 per 100,000. Serogroup B accounted for 62.5% of the serotyped isolates, group C for 23.1%, group A for 7.2%, group W135 for 3.6%, group Y for 1.8%. All tested meningococcal strains were susceptible to penicillin as well as to rifampin. Incidence of meningococcal meningitis in 1994 has been low suggesting that its relative importance compared to other bacteria causing meningitis is likely to change in the future. Therefore, extended surveillance on bacterial meningitis by other etiological agents has to be maintained and implemented in order to undertake the appropriate control measures and evaluate their effect.
Adolescent↗
Molecular characterization of two Bordetella bronchiseptica strains isolated from children with coughs.
During a surveillance program associated with the Italian clinical trial for the evaluation of new acellular pertussis vaccines, two bacterial isolates were obtained in cultures of samples from immunocompetent infants who had episodes of cough. Both clinical isolates were identified as Bordetella bronchiseptica by biochemical criteria, although both strains agglutinated with antisera specific for Bordetella parapertussis, suggesting that the strains exhibited some characteristics of both B. bronchiseptica and B. parapertussis. Both children from whom these strains were isolated exhibited an increase in serum antibody titer to pertussis toxin (PT), a protein that is produced by Bordetella pertussis but that is not thought to be produced by B. bronchiseptica. We therefore examined whether the clinical isolates were capable of producing PT. Neither strain produced PT under laboratory conditions, although both strains appeared to contain a portion of the ptx region that encodes the structural subunits of PT. In order to determine whether the ptx genes may encode functional proteins, we inserted an active promoter directly upstream of the ptx region of one of these strains. Biologically active PT was produced, suggesting that this strain contains the genetic information necessary to encode an active PT molecule. Sequence analysis of the ptx promoter region of both strains indicated that, while they shared homology with the B. bronchiseptica ATCC 4617 sequence, they contained certain sequence motifs that are characteristic of B. parapertussis and certain motifs that are characteristic of B. pertussis. Taken together, these findings suggest that variant strains of B. bronchiseptica exist and might be capable of causing significant illness in humans.
Acute Disease↗
A fatal postpartum Clostridium sordellii associated toxic shock syndrome.
Clostridium sordellii is an infrequent human pathogen. It has been demonstrated to be occasionally responsible for myonecrosis or gas gangrene. Interestingly, in the obstetric literature, some cases of postpartum maternal deaths have been associated with C sordellii infection causing a rapidly lethal toxin mediated syndrome. This is the first reported case of postpartum death in a 29 year old woman, in which a toxigenic C sordellii was isolated from the patient's blood antemortem during the fatal toxic shock, strongly indicating its role in this rare syndrome.
Adult↗
Bordetella parapertussis infections.
The rate of isolation of Bordetella parapertussis among children with cough during the follow-up of different clinical efficacy studies has been evaluated. In the Italian trial, a comparison of clinical characteristics between B. pertussis and B. parapertussis infections showed lower frequencies and shorter duration of typical symptoms of whooping cough such as paroxysmal coughing, whooping, and vomiting in the group of children affected with B. parapertussis infections. In about 70% of B. parapertussis infections, there was a two-fold increase of IgA or IgG anti-FHA from acute- and convalescent-phase serum specimens. The analysis of the distribution of B. parapertussis cases in children fully immunized with each pertussis vaccine suggested that vaccination is irrelevant in preventing B. parapertussis infection.
Adhesins, Bacterial↗
Antibody kinetics and long-term sero-prevalence in the Italian clinical trial of acellular pertussis vaccines.
In the Italian Pertussis Vaccine Trial, data were collected to evaluate the persistence of anti-pertussis antibodies. A sub-cohort of 1275 children was followed for this purpose until a mean age of 21 months. An additional evaluation included pooled cross-sectional analysis of serum specimens collected for analysis of cough illnesses. Antibodies to PT, FHA and PRN were measured by ELISA using a standardized technique. With both acellular vaccines in the study (the Chiron Biocine three-component and SmithKline Beecham three-component vaccines) there was a fast and steep decrease of mean geometric titres for PT, FHA and PRN in the months immediately following vaccination. Titres were close to the detection limit 15 months after the end of primary immunization. The immunogenicity of the whole-cell study vaccine (produced by Connaught Laboratories, Inc. Swiftwater, USA) was poor as determined one month after the third dose and no antibody was detected in nearly all children 15 months after the end of vaccination.
Adhesins, Bacterial↗
Late complications after systemic methotrexate treatment of unruptured ectopic pregnancies: a report of three cases.
BACKGROUND: The use of methotrexate (MTX) by systemic administration in the treatment of unruptured ectopic pregnancy has been reported as a safe and effective method. CASES: We report three cases (one hematosalpinx and two pelvic hematocoeles) of complications after the use of MTX in the treatment of unruptured ectopic pregnancies. All three cases came to our observation for pelvic pain, abnormal bleeding and a pelvic mass after an interval of 3-5 months, subsequent to the disappearance of symptoms and normalization of serum human chorionic gonadotropin beta-subunit (beta-hCG) levels. CONCLUSIONS: These findings suggest that: (a) such complications should be considered before selecting the mode of treatment for ectopic pregnancy; and (b) that an early ultrasonographic control should be performed after MTX treatment even when the decline in beta-hCG levels suggests a successful resolution. This would permit an early diagnosis of these late complications.
Adult↗
A risk model for ovarian carcinoma patients using CA 125: time to normalization renders second-look laparotomy redundant.
BACKGROUND: We evaluated the incorporation of CA 125 normalization times into a prognostic model based on pretreatment variables in patients with ovarian carcinoma to determine if they could render second-look laparotomy (SLL) redundant. METHODS: A total of 54 consecutive patients with ovarian carcinoma who underwent SLL between 1985 and 1990 were included in this analysis. At diagnosis, all of the patients had abnormal CA-125 serum levels, which fell to within the normal range during chemotherapy. Cox's model was used to select pretreatment variables relevant for prognosis. The influence of the time to normalization of CA 125 (< or = vs. > 1 months) and the capability of SLL results to modify prognostic prediction, were also evaluated. RESULTS: The size of the residual tumor at the beginning of therapy, and Eastern Cooperative Oncology Group (ECOG) performance status (PS) were independently predictive of survival. The time to normalization of CA 125 serum levels (analyzed either as -a continuous or as a two-category variable) also had an independent prognostic role when included in the model. When we examined the inclusion of both CA 125 parameter and SLL into the model together, we found that only CA 125 continued to have an independent prognostic relevance. On the basis of the two pretreatment parameters (PS and tumor size) and of this response parameter (time to normalization of CA 125 values) we selected six subgroups of patients having different outcomes (log rank test of equality over-strata < 0.001). Patients with good prognostic pretreatment variables, and those with intermediate prognosis at the beginning of therapy who showed a quick normalization of CA 125, had an 80% 5-year survival, compared with 16% 5-year survival in the remaining patients. (P < 0.0001). CONCLUSIONS: Our data suggest that the survival of patients with advanced ovarian carcinoma could be accurately predicted by considering some pretreatment variables and time to CA 125 normalization together, without performing SLL. Our risk model, however, needs to be validated by larger prospective trials, to draw any definitive conclusions about the abandonment of surgically defined response.
Biomarkers, Tumor↗
A controlled trial of two acellular vaccines and one whole-cell vaccine against pertussis. Progetto Pertosse Working Group.
BACKGROUND: Concern about both safety and efficacy has made the use of whole-cell pertussis vaccines controversial. In some European countries, including Italy, the rate of vaccination against pertussis is low. METHODS: We conducted a double-blind trial in Italy in which infants were randomly assigned to vaccination at two, four, and six months of age with an acellular pertussis vaccine together with diphtheria and tetanus toxoids (DTP); a DTP vaccine containing whole-cell pertussis (manufactured by Connaught Laboratories); or diphtheria and tetanus toxoids without pertussis (DT). The acellular DTP vaccine was either one containing filamentous hemagglutinin, pertactin, and pertussis toxin inactivated with formalin and glutaraldehyde (SmithKline Beecham) or one with filamentous hemagglutinin, pertactin, and genetically detoxified pertussis toxin (Chiron Biocine). Pertussis was defined as 21 days or more of paroxysmal cough, with infection confirmed by culture or serologic testing. RESULTS: The efficacy of each vaccine, given in three doses, against pertussis was determined for 14,751 children over an average of 17 months, with cases included in the analysis if cough began 30 days or more after the completion of immunization. For both of the acellular DTP vaccines, the efficacy was 84 percent (95 percent confidence intervals, 76 to 89 percent for Biocine DTP and 76 to 90 percent for SmithKline DTP), whereas the efficacy of the whole-cell DTP vaccine was only 36 percent (95 percent confidence interval, 14 to 52 percent). The antibody responses were greater to the acellular vaccines than to the whole-cell vaccine. Local and systemic adverse events were significantly more frequent after the administration of the whole-cell vaccine. For the acellular vaccines, the frequency of adverse events was similar to that in the control (DT) group. CONCLUSIONS: The two acellular DTP vaccines we studied were safe, immunogenic, and efficacious against pertussis, whereas the efficacy of the whole-cell DTP vaccine was unexpectedly low.
Antibodies, Bacterial↗
Clostridium difficile: an update on virulence mechanisms.
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Journal Article↗
Heterotopic pregnancy in a woman without previous ovarian hyperstimulation: ultrasound diagnosis and management.
Heterotopic pregnancy (HT) in the absence of a previous ovarian hyperstimulation is a very rare condition. Transvaginal ultrasonography (TV) in the case of first trimester pelvic pain allows a high diagnostic reliability in the identification of HT and a successful conservative treatment by means of TV potassium chloride injection.
Abortion, Therapeutic↗
Polymerase chain reaction for the identification of Bordetella pertussis and Bordetella parapertussis.
The polymerase chain reaction (PCR) for the detection of Bordetella pertussis and Bordetella parapertussis DNA in clinical samples was well documented by recent studies. Different regions in Bordetella pertussis DNA have been successfully used as targets for this method by various authors. In this work we report the usefulness of the PCR assay also for speciating Bordetellae isolates in those cases where the biochemical and serological tests gave inconclusive results.
Agglutination↗
Polymerase chain reaction for the detection of Bordetella pertussis in clinical nasopharyngeal aspirates.
A PCR procedure for the detection of Bordetella pertussis in nasopharyngeal aspirates (NPAs) was developed with primers derived from the pertussis toxin promoter region. The amplification resulted in a 191-bp PCR product specific for B. pertussis. A total of 681 NPAs collected from children with cough lasting >7 days was evaluated by PCR and culture; 104 aspirates were positive by PCR and 93 by culture. Sixteen cases were positive only by PCR and five culture positive aspirates were negative by PCR. An internal control was included in the assay to monitor the performance of the PCR and to identify possible inhibitory components in clinical samples. The PCR method was more efficient than culture in detecting B. pertussis in samples collected late in the disease, in antibiotic-treated children and in patients with mild disease.
Bordetella pertussis↗
Oligonucleotide probes for detection of cephalosporinases among Bacteroides strains.
Two oligonucleotide probes selected from the sequences of cepA and cfxA genes, respectively, were used to detect beta-lactamase production among strains of the Bacteroides fragilis group. By using these probes, colony hybridization was shown to be a specific and rapid method for identifying the more prevalent beta-lactamase, CepA, and the rarer CfxA enzyme among B. fragilis strains.
Bacteroides↗
Superovulation with urinary human follicle-stimulating hormone: correlations with body mass index and body fat distribution.
Our objective was to investigate the relationship between body mass index (BMI), waist/hip ratio (WHR), follicle-stimulating hormone (FSH) dose, length of stimulation and clinical outcome in infertile women with and without polycystic ovary syndrome (PCOS) undergoing controlled ovarian hyperstimulation. Controlled ovarian hyperstimulation was induced in 60 women for a total of 111 cycles (48% in PCOS patients) with urinary human FSH (u-hFSH). A significant correlation between BMI, u-hFSH dose and duration of stimulation was found in PCOS and non-PCOS patients with WHR < 0.8. These correlations were not present in PCOS patients with WHR > 0.8. Pregnant patients received significantly less ampules of u-hFSH. From our data we suggest a controlled ovarian hyperstimulation protocol, for obese non-PCOS patients and obese PCOS patients with WHR < 0.8, starting with a double dose of u-FSH.
Adipose Tissue↗
Carboplatin (CBDCA)-hexamethylmelamine (HMM)-oral etoposide (VP-16) first-line treatment of ovarian cancer patients with bulky disease: a phase II study.
Hexamethylmelamine (HMM) and oral etoposide (VP-16) have shown to be active against platinum-resistant epithelial ovarian cancer. On this basis a three-drug regimen including carboplatin (CBDCA) plus HMM and oral VP-16 was tested in previously untreated ovarian cancer patients with tumor size > 2 cm. Since October 1991, 29 chemotherapy-naive ovarian cancer patients with tumor larger than 2 cm (20 stage III and 9 stage IV) have been treated for a total of 153 courses. CBDCA was administered i.v. on Day 1. The dose was individualized using the Calvert formula (the target dose was AUC = 5). VP-16 was administered orally at the dose of 50 mg/m2 Days 1-14, HMM at the dose of 150 mg/m2 po Days 14-28. Therapy was repeated every 28 days for a total of 6 courses. In order to avoid severe leukopenia and delays in the treatment administration, G-CSF 5 micrograms/kg/day sc Days 8-14 (or until postnadir recovery of neutrophil count > 10,000/mm3) and Days 22-28 was administered. All patients were evaluable for toxicity. No treatment-related deaths occurred. Myelotoxicity was the main side effect. It was grade 3-4 in a total of 13/29(45%) patients. One patient discontinued treatment after the first course due to HMM-related gastrointestinal toxicity. The actual delivered dose intensity was 89% of the planned dose. At the time of this analysis (April 1994) 26 patients are evaluable for response. Fifteen patients achieved a clinical complete remission and 9 a partial response for a 92% overall response rate. Fourteen patients accepted second-look laparotomy. We observed 11 pathological complete regressions (42%; 95% CI, 21-63). At a median follow-up of 16 months 3 deaths have occurred. Only 2 patients with NED at second-look laparotomy have relapsed. We stopped the accrual since the 95% confidence interval of the pCR-rate observed exceeded 20%. This new first-line regimen seems to be highly effective in patients with poor-prognosis advanced ovarian cancer, although the data are not yet sufficiently mature for a final analysis of time to progression and overall survival.
Administration, Oral↗
Role of Clostridium difficile in childhood diarrhea.
To investigate the etiologic role of Clostridium difficile in childhood acute diarrhea, stool specimens from 618 children with diarrhea and 135 controls without enteric symptoms were examined by cell culture assay for the presence of free toxin B. This toxin was found in 4.2% of the fecal specimens examined without finding a significant difference between cases and controls, suggesting no causal relationship between diarrhea and the presence of free C. difficile toxin B. C. difficile strains isolated from toxin B-positive specimens were characterized by cytotoxin and enterotoxin production and by sodium dodecyl sulfate-polyacrylamide gel electrophoresis of EDTA-extracted proteins. All but two isolates produced toxin B and toxin A and the remaining were negative for both toxins. Polyacrylamide gel electrophoresis analysis showed eight electrophoretic types, none of them was clearly related with the cases of diarrhea. The majority of isolates from children with diarrhea did not belong to types previously observed in adults with pseudomembranous colitis or antibiotic-associated diarrhea. This study provides additional evidence that C. difficile is not involved in the etiology of childhood diarrhea.
Bacterial Toxins↗
Computerized tomography of the abdomen and pelvis with peritoneal administration of soluble contrast (IPC-CT) in detection of residual disease for patients with ovarian cancer.
Forty-five ovarian cancer patients were submitted to abdominopelvic computed tomography after intraperitoneal administration of soluble contrast in large fluid volumes (3 liters of normal saline) (IPC-CT), for a total of 66 exams. In all cases standard abdominopelvic CT scanning had previously missed the presence of disease. Peritoneal access was achieved by a temporary Teflon catheter inserted blindly. No major complications related to peritoneal access or fluid administration occurred. Laparotomy was performed in all cases to evaluate accuracy of this new diagnostic procedure. Overall, 32/66 exams showed no abnormal findings. In 9/32 cases persistence of disease was demonstrated by laparotomy. The remaining 34 exams were suggestive of persistence of tumor. In 19 cases CT scan showed nodular images or peritoneal thickness. Persistence of disease was confirmed by laparotomy in all instances. In 15 cases only an abnormal diffusion of soluble contrast into peritoneum (suprahepatic, anterior, or parietocolic region) was demonstrated. In 11/15 persistence of tumor was found at laparotomy. To summarize, IPC-CT revealed persistence of tumor in 30/39 cases (77% sensitivity). Positive results were predictive of persistence of disease in 30/34 cases (88% specificity). This new procedure was able to detect persistence of disease in most of our patients showing negative standard CT (30/39 vs 0/39; P < 10E-8) and its diagnostic accuracy was even better than standard CT+serum tumor markers (30/39 vs 16/39; P < 0.001). In conclusion, IPC-CT could be very effective in monitoring response to treatment and could markedly reduce the number of ovarian cancer patients requiring second-look laparotomy.
Adult↗