Clinical trial NCT01232530: Pharmacovigilance for ACTs in Africa
Official title: Pharmacovigilance for Artemisinin-based Combination Treatments in Africa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malaria
Keywords: Malria, ACT, Safety, Efficacy, pregarnancy
Lead sponsor: Centre Muraz
Sponsor class: OTHER
Collaborators: name: World Health Organization
First posted: 2010-11-02
Enrollment: 3176
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Initially, a census of the population living in Nanoro department and around (approximately 50,000 people) will be carried out. The complete census database will be utilized to estimate the incidence of malaria episodes and to determine whether there is any clustering of malaria episodes as well as AEs. Such census will be updated by a team of 8 field workers who will visit each single household every 4 months, for at least 3 years to identify newly pregnant women and to collect information on vital events such as births and deaths. Of the 50,000 people in the census database, approximately 25,000 will be under active surveillance while the other 25,000 will be under passive surveillance.

Brief summary: This is a phase IV open label study assessing the safety and effectiveness of artemisinin derivatives-based combination therapy (ACT) when used on a large scale and under "real life" conditions.

Detailed description: The study will be conducted in a well defined population in Burkina Faso by setting up a population-based monitoring system.

The monitoring for adverse events (AEs) will use two approaches (active and passive) based on a repeat survey of the study population. The active surveillance population will be weekly and actively visited at home at day 7, day 14 and day 28 after drug administration. The passive surveillance population will be encouraged to report passively any AE/ADR and they will NOT be actively visited at home.

In addition, the possible exposure to ACTs of all the pregnant women identified during the repeat surveys in both the active and passive surveillance areas will be extracted from the drug exposure log book or elicited by history, and the data will be entered into a pregnancy register.

For the effectiveness study, patients with a microscopically confirmed diagnosis of malaria (any parasite density), clinical symptoms and a blood sample for thick and thin blood smears, and later PCR analysis (on filter paper) for genotyping will be collected before antimalarial treatment, at day 28 after treatment and at any unscheduled visit. This will be repeated for each confirmed malaria episode.

Eligibility criteria: Inclusion Criteria:

* Males and Females living in Nanoro DSS catchment area;
* Signed (or thumb-printed whenever patients are illiterate) informed consent.
* Patients' willingness and ability to comply with the study protocol for the duration of the study.

Exclusion Criteria:

* Severe malaria.
* Danger signs: not able to drink or breast-feed, vomiting (\> twice in 24hours), recent history of convulsions (\>1 in 24h), unconscious state, unable to sit or stand.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nanoro
country: Burkina Faso
facility: Clinical Research Unit of Nanoro (CRUN) / Centre Muraz
state: Boulkiemdé
Study officials:
affiliation: Centre Muraz
name: Halidou Tinto, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sondo P, Bihoun B, Tahita MC, Derra K, Rouamba T, Nakanabo Diallo S, Kazienga A, Ilboudo H, Valea I, Tarnagda Z, Sorgho H, Lefevre T, Tinto H. Plasmodium falciparum gametocyte carriage in symptomatic patients shows significant association with genetically diverse infections, anaemia, and asexual stage density. Malar J. 2021 Jan 7;20(1):31. doi: 10.1186/s12936-020-03559-0.
citation: Sondo P, Derra K, Diallo Nakanabo S, Tarnagda Z, Kazienga A, Zampa O, Valea I, Sorgho H, Owusu-Dabo E, Ouedraogo JB, Guiguemde TR, Tinto H. Artesunate-Amodiaquine and Artemether-Lumefantrine Therapies and Selection of Pfcrt and Pfmdr1 Alleles in Nanoro, Burkina Faso. PLoS One. 2016 Mar 31;11(3):e0151565. doi: 10.1371/journal.pone.0151565. eCollection 2016.
citation: Tinto H, Sevene E, Dellicour S, Calip GS, d'Alessandro U, Macete E, Nakanabo-Diallo S, Kazienga A, Valea I, Sorgho H, Vala A, Augusto O, Ruperez M, Menendez C, Ouma P, Desai M, Ter Kuile F, Stergachis A. Assessment of the safety of antimalarial drug use during early pregnancy (ASAP): protocol for a multicenter prospective cohort study in Burkina Faso, Kenya and Mozambique. Reprod Health. 2015 Dec 4;12:112. doi: 10.1186/s12978-015-0101-0.
citation: Sondo P, Derra K, Diallo-Nakanabo S, Tarnagda Z, Zampa O, Kazienga A, Valea I, Sorgho H, Owusu-Dabo E, Ouedraogo JB, Guiguemde TR, Tinto H. Effectiveness and safety of artemether-lumefantrine versus artesunate-amodiaquine for unsupervised treatment of uncomplicated falciparum malaria in patients of all age groups in Nanoro, Burkina Faso: a randomized open label trial. Malar J. 2015 Aug 20;14:325. doi: 10.1186/s12936-015-0843-8.