MalariaPhase 3NCT00274235
Intermittent Preventive Treatment During Pregnancy in Benin
A Phase 3 study testing sulfadoxine-pyrimethamine / mefloquine in people with Malaria, run by Institut de Recherche pour le Developpement at 1 site in Benin.
Trial summary
Malaria in pregnancy is one of the most important preventable causes of low birthweight worlwide and a major cause of severe maternal anaemia contributing to maternal mortality. Intermittent Preventive Treatment (IPT) with sulfadoxine-pyrimethamine (SP) is the currently adopted government recommendation for malaria… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Malaria
- What is being tested?
- sulfadoxine-pyrimethamine / mefloquine
- How many people
- 1,600 participants
- Where
- 1 siteBenin
- Study dates
- Jul 2005to Apr 2008
- Phase
- Phase 3
- 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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnancy between 16 and 28 weeks of gestation
- Residence near the maternity clinics
- Intention to continue the ante-natal care and deliver at the study maternity clinic
- Ability to take drugs by oral route
- Written informed consent (parents or guardian if aged < 18 years)
Who cannot join
- Pregnancy prior to 16 weeks or after 28 weeks of gestation
- Previous suspected reaction to sulfadoxine-pyrimethamine or mefloquine
- History of neurological or psychiatric event
- Intake of sulfadoxine-pyrimethamine or mefloquine within 4 weeks of enrollment
- Current treatment with halofantrine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intermittent Preventive Treatment During Pregnancy in Benin: a Randomized, Open, and Equivalent Trial Comparing Sulfadoxine-Pyrimethamine With Mefloquine
Malaria in pregnancy is one of the most important preventable causes of low birthweight worlwide and a major cause of severe maternal anaemia contributing to maternal mortality. Intermittent Preventive Treatment (IPT) with sulfadoxine-pyrimethamine (SP) is the currently adopted government recommendation for malaria control during pregnancy in Benin, but the emergence and the spread of resistance to SP justifies the evaluation of alternative anti-malarial drugs. Mefloquine (MQ), which has been proven effective and reasonably safe in this indication, may be an interesting alternative to SP. The aim of this trial is to compare the efficacy and safety of sulfadoxine-pyrimethamine and mefloquine for IPT. It is an equivalent study designed to test the hypothesis that MQ is as efficacious as SP to prevent malaria in pregnancy, and that it could replace SP when resistance of Plasmodium falciparum becomes too elevated. Primary endpoint will be the proportion of infants with low birthweight. Secondary endpoints will be the proportion of mothers with placental plasmodial infection, and the proportion of mothers with anaemia at delivery.
Read the detailed description
The trial will be conducted in two maternity clinics in Ouidah, 40km from Cotonou. A total of 1600 women will be selected and randomised to receive either SP (1500 mg sulfadoxine with 75 mg pyrimethamine) or MQ (15 mg/kg) twice during pregnancy at ante-natal clinic (ANC) visits. The first dose will be given between 16 and 28 weeks of gestation, the second between 30 and 36 weeks, and at least one month after the first dose. Women will be visited at home within one week after the initial and subsequent ANC visits to check for adverse reactions due to the study drugs. Peripheral blood samples will be collected on each ANC visit to assess for haemoglobin level and parasitemia. Peripheral, placental, and cord blood samples will be collected at delivery for haematological determinations and parasitological examination. Birthweight will be recorded and the gestational age assessed by the Ballard method. The mother and her child will be assessed for general health status six weeks after birth.
- Conditions
- Malaria
- Being tested
- sulfadoxine-pyrimethamine / mefloquine
- Keywords
- Malaria, Prevention, Pregnancy, Low birthweight, Anemia, Africa
- Medical subject headings
- Malaria, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sulfadoxine-pyrimethamine / mefloquineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of infants with low birthweight (<2,500 grams)
Secondary outcomes (8)
mean birthweight
proportion of mothers with placental plasmodial infection
proportion of preterm deliveries
proportion of mothers with anaemia (Haemoglobin level (Hb)<11g/dl) and severe anaemia (Hb<8g/dl) at delivery
proportion of mothers with parasitaemia at delivery
proportion of adverse events after taking study drugs
proportion of congenital abnormalities
proportion of stillbirths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2006 (estimated)
- Study startJul 2005
- Primary completionMar 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche pour le Developpement
- Sponsor type
- Other government
- Collaborators
- National Malaria Control Program, Benin, Ministry of Foreign Affairs, France, Institut des Sciences Biomédicales Appliquées, Bénin, Faculté des Sciences de la Santé, Bénin
- Investigators
- Michel Cot, MD, Principal investigator, Institut de Recherche pour le Developpement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274235
- Sponsor's protocol ID
- UR10_01_2005
- Status last verified
- Oct 2008
- First submitted
- 9 Jan 2006
- Last updated
- 31 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Briand V, Bottero J, Noel H, Masse V, Cordel H, Guerra J, Kossou H, Fayomi B, Ayemonna P, Fievet N, Massougbodji A, Cot M. Intermittent treatment for the prevention of malaria during pregnancy in Benin: a randomized, open-label equivalence trial comparing sulfadoxine-pyrimethamine with mefloquine. J Infect Dis. 2009 Sep 15;200(6):991-1001. doi: 10.1086/605474.
PubMed 19656069Briand V, Denoeud L, Massougbodji A, Cot M. Efficacy of intermittent preventive treatment versus chloroquine prophylaxis to prevent malaria during pregnancy in Benin. J Infect Dis. 2008 Aug 15;198(4):594-601. doi: 10.1086/590114.
PubMed 18598190
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Preventive Treatment During Pregnancy in Benin: a Randomized, Open, and Equivalent Trial Comparing Sulfadoxine-Pyrimethamine With Mefloquine
- ClinicalTrials.gov ID
- NCT00274235
- Acronym / sponsor ID
- UR10_01_2005
- Conditions
- Malaria
- Keywords
- Malaria, Prevention, Pregnancy, Low birthweight, Anemia, Africa
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Institut de Recherche pour le DeveloppementOther government
- Collaborators
- National Malaria Control Program, Benin, Ministry of Foreign Affairs, France, Institut des Sciences Biomédicales Appliquées, Bénin, Faculté des Sciences de la Santé, Bénin
- Study start
- Jul 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 10 Jan 2006 (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.
Malaria in pregnancy is one of the most important preventable causes of low birthweight worlwide and a major cause of severe maternal anaemia contributing to maternal mortality. Intermittent Preventive Treatment (IPT) with sulfadoxine-pyrimethamine (SP) is the currently adopted government recommendation for malaria control during pregnancy in Benin, but the emergence and the spread of resistance to SP justifies the evaluation of alternative anti-malarial drugs. Mefloquine (MQ), which has been proven effective and reasonably safe in this indication, may be an interesting alternative to SP. The aim of this trial is to compare the efficacy and safety of sulfadoxine-pyrimethamine and mefloquine for IPT. It is an equivalent study designed to test the hypothesis that MQ is as efficacious as SP to prevent malaria in pregnancy, and that it could replace SP when resistance of Plasmodium falciparum becomes too elevated. Primary endpoint will be the proportion of infants with low birthweight. Secondary endpoints will be the proportion of mothers with placental plasmodial infection, and the proportion of mothers with anaemia at delivery.
Detailed description
The trial will be conducted in two maternity clinics in Ouidah, 40km from Cotonou. A total of 1600 women will be selected and randomised to receive either SP (1500 mg sulfadoxine with 75 mg pyrimethamine) or MQ (15 mg/kg) twice during pregnancy at ante-natal clinic (ANC) visits. The first dose will be given between 16 and 28 weeks of gestation, the second between 30 and 36 weeks, and at least one month after the first dose. Women will be visited at home within one week after the initial and subsequent ANC visits to check for adverse reactions due to the study drugs. Peripheral blood samples will be collected on each ANC visit to assess for haemoglobin level and parasitemia. Peripheral, placental, and cord blood samples will be collected at delivery for haematological determinations and parasitological examination. Birthweight will be recorded and the gestational age assessed by the Ballard method. The mother and her child will be assessed for general health status six weeks after birth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnancy between 16 and 28 weeks of gestation
- Residence near the maternity clinics
- Intention to continue the ante-natal care and deliver at the study maternity clinic
- Ability to take drugs by oral route
- Written informed consent (parents or guardian if aged < 18 years)
Key exclusion criteria (5 listed)
- Pregnancy prior to 16 weeks or after 28 weeks of gestation
- Previous suspected reaction to sulfadoxine-pyrimethamine or mefloquine
- History of neurological or psychiatric event
- Intake of sulfadoxine-pyrimethamine or mefloquine within 4 weeks of enrollment
- Current treatment with halofantrine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sulfadoxine-pyrimethamine / mefloquine | Drug | – |
Primary outcome
proportion of infants with low birthweight (<2,500 grams)
8 secondary outcomes
mean birthweight
proportion of mothers with placental plasmodial infection
proportion of preterm deliveries
proportion of mothers with anaemia (Haemoglobin level (Hb)<11g/dl) and severe anaemia (Hb<8g/dl) at delivery
proportion of mothers with parasitaemia at delivery
proportion of adverse events after taking study drugs
proportion of congenital abnormalities
proportion of stillbirths
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 Oct 2008.
- Derived from this study: PubMed 19656069Briand V, Bottero J, Noel H, Masse V, Cordel H, Guerra J, Kossou H, Fayomi B, Ayemonna P, Fievet N, Massougbodji A, Cot M. Intermittent treatment for the prevention of malaria during pregnancy in Benin: a randomized, open-label equivalence trial comparing sulfadoxine-pyrimethamine with mefloquine. J Infect Dis. 2009 Sep 15;200(6):991-1001. doi: 10.1086/605474.
- Derived from this study: PubMed 18598190Briand V, Denoeud L, Massougbodji A, Cot M. Efficacy of intermittent preventive treatment versus chloroquine prophylaxis to prevent malaria during pregnancy in Benin. J Infect Dis. 2008 Aug 15;198(4):594-601. doi: 10.1086/590114.
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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.
Michel Cot, MD principal investigator
Institut de Recherche pour le Developpement
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sulfadoxine-pyrimethamine / mefloquine in people with Malaria, run by Institut de Recherche pour le Developpement at 1 site in Benin.
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 5 inclusion and 5 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 Oct 2008. 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 Benin. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
proportion of infants with low birthweight (<2,500 grams). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00274235, which also lists 2 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 Oct 2008.