Triangular test applied to the clinical trial of azithromycin against relapses in Plasmodium vivax infections
Abstract 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 conc...
Published in: | Malaria Journal |
---|---|
Main Authors: | , , , |
Format: | Article in Journal/Newspaper |
Language: | English |
Published: |
BMC
2002
|
Subjects: | |
Online Access: | https://doi.org/10.1186/1475-2875-1-13 https://doaj.org/article/7a4109612d8a444793f6968e5039d2d7 |
id |
ftdoajarticles:oai:doaj.org/article:7a4109612d8a444793f6968e5039d2d7 |
---|---|
record_format |
openpolar |
spelling |
ftdoajarticles:oai:doaj.org/article:7a4109612d8a444793f6968e5039d2d7 2023-05-15T15:11:13+02:00 Triangular test applied to the clinical trial of azithromycin against relapses in Plasmodium vivax infections Delmont Jean Badiaga Sékéné Ranque Stéphane Brouqui Philippe 2002-11-01T00:00:00Z https://doi.org/10.1186/1475-2875-1-13 https://doaj.org/article/7a4109612d8a444793f6968e5039d2d7 EN eng BMC http://www.malariajournal.com/content/1/1/13 https://doaj.org/toc/1475-2875 doi:10.1186/1475-2875-1-13 1475-2875 https://doaj.org/article/7a4109612d8a444793f6968e5039d2d7 Malaria Journal, Vol 1, Iss 1, p 13 (2002) Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 article 2002 ftdoajarticles https://doi.org/10.1186/1475-2875-1-13 2022-12-31T08:32:29Z Abstract 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 ≥ 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. Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic Malaria Journal 1 1 13 |
institution |
Open Polar |
collection |
Directory of Open Access Journals: DOAJ Articles |
op_collection_id |
ftdoajarticles |
language |
English |
topic |
Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 |
spellingShingle |
Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 Delmont Jean Badiaga Sékéné Ranque Stéphane Brouqui Philippe Triangular test applied to the clinical trial of azithromycin against relapses in Plasmodium vivax infections |
topic_facet |
Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 |
description |
Abstract 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 ≥ 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. |
format |
Article in Journal/Newspaper |
author |
Delmont Jean Badiaga Sékéné Ranque Stéphane Brouqui Philippe |
author_facet |
Delmont Jean Badiaga Sékéné Ranque Stéphane Brouqui Philippe |
author_sort |
Delmont Jean |
title |
Triangular test applied to the clinical trial of azithromycin against relapses in Plasmodium vivax infections |
title_short |
Triangular test applied to the clinical trial of azithromycin against relapses in Plasmodium vivax infections |
title_full |
Triangular test applied to the clinical trial of azithromycin against relapses in Plasmodium vivax infections |
title_fullStr |
Triangular test applied to the clinical trial of azithromycin against relapses in Plasmodium vivax infections |
title_full_unstemmed |
Triangular test applied to the clinical trial of azithromycin against relapses in Plasmodium vivax infections |
title_sort |
triangular test applied to the clinical trial of azithromycin against relapses in plasmodium vivax infections |
publisher |
BMC |
publishDate |
2002 |
url |
https://doi.org/10.1186/1475-2875-1-13 https://doaj.org/article/7a4109612d8a444793f6968e5039d2d7 |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
Malaria Journal, Vol 1, Iss 1, p 13 (2002) |
op_relation |
http://www.malariajournal.com/content/1/1/13 https://doaj.org/toc/1475-2875 doi:10.1186/1475-2875-1-13 1475-2875 https://doaj.org/article/7a4109612d8a444793f6968e5039d2d7 |
op_doi |
https://doi.org/10.1186/1475-2875-1-13 |
container_title |
Malaria Journal |
container_volume |
1 |
container_issue |
1 |
container_start_page |
13 |
_version_ |
1766342114798469120 |