MalariaPVACTNCT01232530
Pharmacovigilance for ACTs in Africa
An observational study of Malaria, run by Centre Muraz at 1 site in Burkina Faso.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malaria
- How many people
- 3,176 participants
- Where
- 1 siteBurkina Faso
- Study dates
- Jun 2010to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Burkina Faso1 site
Clinical Research Unit of Nanoro (CRUN) / Centre Muraz
Nanoro, Boulkiemdé, 211
About this study
Official title: Pharmacovigilance for Artemisinin-based Combination Treatments in Africa
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.
Read the 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.
- Conditions
- Malaria
- Keywords
- Malria, ACT, Safety, Efficacy, pregarnancy
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Safety Active Surveillance Group | For the active surveillance, all age groups, including children less than 5 years of age, will be identified from the census database and encouraged to attend the health facility whenever sick. Those with a diagnosis of malaria and treated with an antimalarial drug will be actively monitored for AEs. | |
| Safety Passive Surveillance Group | For the people under passive surveillance, sick subjects attending the health facilities, diagnosed with malaria and treated with an antimalarial drug will be identified from the census database. The treatment administered will be recorded in a drug exposure log book and the patients will be encouraged to report passively any AE/ADR. | |
| Early Pregnancy Exposure to ACTs Group | All the pregnant women identified during the repeat surveys will be included in a pregnancy cohort. At the time the pregnant woman is identified, her possible exposure to ACTs will be extracted from the drug exposure log book or elicited by history. Births identified through the repeat surveys or any other outcome of pregnancy will be retrospectively matched with antimalarial treatment exposure, particularly during the first trimester of the pregnancy. | |
| ACT Effectiveness Monitoring Group | Besides monitoring AEs and ADRs, data on the effectiveness of ACTs when used in "real life" conditions and on a large scale will be collected in the active surveillance area. For patients with a microscopically confirmed diagnosis of malaria, clinical symptoms and a blood sample for thick and thin blood smears, will be collected before antimalarial treatment, at day 28 after treatment and at any unscheduled visit. Treatment administration will not be supervised. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Muraz
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization
- Responsible party
- Principal investigator, Tinto Halidou, Centre Muraz
- Investigators
- Halidou Tinto, PharmD, PhD, Principal investigator, Centre Muraz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232530
- Sponsor's protocol ID
- WHO/TDR - A70283
- Acronym
- PVACT
- Status last verified
- Jul 2015
- First submitted
- 1 Nov 2010
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33413393Sondo 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.
PubMed 27031231Tinto 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.
PubMed 26637464Sondo 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.
PubMed 26289949
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacovigilance for Artemisinin-based Combination Treatments in Africa
- ClinicalTrials.gov ID
- NCT01232530
- Acronym / sponsor ID
- PVACT / WHO/TDR - A70283
- Conditions
- Malaria
- Keywords
- Malria, ACT, Safety, Efficacy, pregarnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,176 participants (actual)
- Lead sponsor
- Centre MurazUniversity, hospital or other
- Collaborators
- World Health Organization
- Study start
- Jun 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 2 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Safety Active Surveillance Group | – | –For the active surveillance, all age groups, including children less than 5 years of age, will be identified from the census database and encouraged to attend the health facility whenever sick. Those with a diagnosis of malaria and treated with an antimalarial drug will be actively monitored for AEs. |
| Safety Passive Surveillance Group | – | –For the people under passive surveillance, sick subjects attending the health facilities, diagnosed with malaria and treated with an antimalarial drug will be identified from the census database. The treatment administered will be recorded in a drug exposure log book and the patients will be encouraged to report passively any AE/ADR. |
| Early Pregnancy Exposure to ACTs Group | – | –All the pregnant women identified during the repeat surveys will be included in a pregnancy cohort. At the time the pregnant woman is identified, her possible exposure to ACTs will be extracted from the drug exposure log book or elicited by history. Births identified through the repeat surveys or any other outcome of pregnancy will be retrospectively matched with antimalarial treatment exposure, particularly during the first trimester of the pregnancy. |
| ACT Effectiveness Monitoring Group | – | –Besides monitoring AEs and ADRs, data on the effectiveness of ACTs when used in "real life" conditions and on a large scale will be collected in the active surveillance area. For patients with a microscopically confirmed diagnosis of malaria, clinical symptoms and a blood sample for thick and thin blood smears, will be collected before antimalarial treatment, at day 28 after treatment and at any unscheduled visit. Treatment administration will not be supervised. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
- Derived from this study: PubMed 33413393Sondo 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.
- Derived from this study: PubMed 27031231Sondo 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.
- Derived from this study: PubMed 26637464Tinto 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.
- Derived from this study: PubMed 26289949Sondo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Halidou Tinto, PharmD, PhD principal investigator
Centre Muraz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria, run by Centre Muraz at 1 site in Burkina Faso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01232530, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2015.