Search PubMed⌕ Search

Biomedical subjects

Jean Delmont

Publications and source records attributed to Jean Delmont.

4 recordsLinked to original sources

Triangular test applied to the clinical trial of azithromycin against relapses in Plasmodium vivax infections.

BACKGROUND: Sequential analysis enables repeated statistical analyses to be performed throughout a trial recruitment period, while maintaining a pre-specified power and type I error. Thus the trial can be stopped as soon as the information accumulated is considered sufficient to reach a conclusion. Sequential tests are easy to use and their statistical properties are especially suitable to trials with very straightforward objectives such as non-comparative phase II trials. We report on a phase II study based on the triangular test (TT) aiming at assessing the effectiveness of azithromycin in preventing Plasmodium vivax relapses. METHODS: To test whether the P. vivax relapse rate was either <12% or >or= 45% in patients treated with azithromycin, a sequential analysis based on the TT was as used. Patients infected with P. vivax were treated with azithromycin, 1.2 g daily, for 7 days. The onset of a relapse infection was monitored. RESULTS: Five patients presenting with an acute P. vivax infection were included in the study. All the patients were initially cured. Three patients reported mild gastrointestinal adverse effects. When the third patient relapsed, the sample path crossed the upper boundary of the TT, and the trial was stopped. CONCLUSIONS: Using the triangular test, with only a small number of patients, we concluded that azithromycin was not effective enough in preventing P. vivax relapses to warrant further evaluation in phase III. It is suggested that a wider use of sequential analysis in phase II anti-infective drugs trials may have financial and ethical benefits.

Adolescent↗

[Malaria].

Explore the source record for details and available documents.

Animals↗

Contribution of nonspecific laboratory test to the diagnosis of malaria in febrile travelers returning from endemic areas: value of hypocholesterolemia.

BACKGROUND: The gold standard in diagnosis of malaria is microscopic detection of malaria parasites in thin blood smears. However, the sensitivity and specificity of blood smears depend mostly on the experience of the examiner. In the traveler returning from the tropics, diagnosis of malaria may be difficult when the parasitemia is low. In this circumstance any indicator that suggests the diagnosis of malaria is of great interest. The aim of this study is to determine the value of hypocholesterolemia to the diagnosis of imported malaria. METHOD: A retrospective case-control study was performed among hospitalized patients with fever returning from a malaria-endemic area, to compare the results of routine biological parameters of 129 malaria cases with those of 92 control patients. RESULTS: Multivariate analysis, using a logistic regression model demonstrates that hypocholesterolemia was the strongest parameter associated with malaria (adjusted odds ratio [OR]: 75.22, 95% confidence interval [CI] 4.60-1227.78) and the most specific (98%, 95% CI 0.95-1.0). The most sensitive abnormality was thrombocytopenia (82%, 95% CI-0.77 0.87). With a malaria prevalence of 52% in our population study, hypocholesterolemia has the strongest positive predictive value among routine biological parameters for malaria diagnosis (96%). The combination of hypocholesterolemia and thrombocytopenia was always associated with diagnosis of malaria in this study. CONCLUSION: These results show that hypocholesterolemia is significantly associated with malaria. Therefore, in the setting of negative thin and thick blood smears, the presence of hypocholesterolemia, particularly when it is combined with thrombocytopenia, in a febrile traveler returning from a malaria-endemic area, should prompt repetition and careful analysis of blood smears to avoid misdiagnosis.

Adult↗