PregnancyMiPPADNCT00811421
Evaluation of Alternative Antimalarial Drugs for Malaria in Pregnancy
A study testing Sulphadoxine-pyrimethamine, Mefloquine (full dose) and Mefloquine (split dose) in people with Pregnancy and Malaria, run by Hospital Clinic of Barcelona at 5 sites in 5 countries.
Trial summary
The study aims at comparing the safety, tolerability and efficacy of Mefloquine (MQ) to Sulfadoxine-Pyrimethamine (SP) as Interment Preventive Treatment in pregnancy (IPTp) for the prevention of malaria effects on the mother and her infant. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Malaria, HIV Infections
- What is being tested?
- Sulphadoxine-pyrimethamine, Mefloquine (full dose) and Mefloquine (split dose)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5,820 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Sep 2009to Dec 2013
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Trial 1:
- Permanent resident in the area
- Gestational age at the first antenatal visit ≤ 28 weeks
- Signed informed consent
- Agreement to deliver in the study site's maternity(ies) wards
- Trial 2:
Show all 12Show fewer
- Permanent resident in the area.
- Gestational age at the first antenatal visit ≤ 28 weeks
- HIV seropositive (after voluntary counseling and testing)
- Indication to receive CTX prophylaxis (according to the national guidelines)
- Signed informed consent
- Agreement to deliver in the study site's maternity(ies) wards.
Who cannot join
- Trial 1:
- Residence outside the study area or planning to move out in the following 18 months from enrollment
- Gestational age at the first antenatal visit > 28 weeks of pregnancy
- Known history of allergy to sulfa drugs or mefloquine
- Known history of severe renal, hepatic, psychiatric or neurological disease
- MQ or halofantrine treatment in the preceding 4 weeks
Show all 14Show fewer
- HIV infection
- Participating in other studies
- Trial 2:
- Residence outside the study area or planning to move out in the following 10 months from enrollment
- Gestational age at the first antenatal visit > 28 weeks of pregnancy
- Known history of allergy to CTX or MQ
- Known history of severe renal, hepatic, psychiatric or neurological disease
- MQ or halofantrine treatment in the preceding 4 weeks
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Benin1 site
Faculté des Sciences de la Santé (FSS), Université d'Abomey Calavi
Allada
Mozambique1 site
Centro de Investigaçao em Saúde da Manhiça (CISM)
Manhiça, Maputo Province
About this study
Official title: Evaluation of the Safety and Efficacy of Mefloquine as Intermittent Preventive Treatment of Malaria in Pregnancy
The study aims at comparing the safety, tolerability and efficacy of Mefloquine (MQ) to Sulfadoxine-Pyrimethamine (SP) as Interment Preventive Treatment in pregnancy (IPTp) for the prevention of malaria effects on the mother and her infant.
Read the detailed description
The current recommendation by the World Health Organization (WHO) to prevent malaria infection in pregnancy in areas of stable malaria transmission relies on:
- Prompt and effective case management of malaria illness
- The use of intermittent preventive treatment (IPTp) with at least 2 treatment doses of sulfadoxine-pyrimethamine (SP) and
- The use of insecticide treated nets (ITNs)
However, the spread of parasite resistance to SP, particularly in eastern Africa, and the significant overlap in some regions of malaria transmission and high prevalence of HIV infection, have raised concerns about the medium and long-term use of SP for IPTp.
HIV infection increases susceptibility to malaria and may reduce the efficacy of interventions. The evaluation of alternative antimalarials for IPTp is thus urgently needed also involving HIV infected women.
Of all the current available alternative antimalarial drugs, mefloquine (MQ) is the one that offers the most comparative advantages to SP.
A randomized multicenter trial will be conducted in 4 sites in Africa (Benin, Gabon, Tanzania and Mozambique) in order to compare the safety and efficacy of SP versus MQ as IPTp in the context of ITNs. In addition, MQ tolerability will be also evaluated by comparing the administration of MQ as a single intake with its administration as split dose in two days. In total 4716 pregnant women will be enrolled at the antenatal clinic (ANC) and will be followed until the infant is one year old.
Besides, in those countries where HIV prevalence in pregnant women is > 10%, MQ-IPTp will be compared to Placebo-IPTp in HIV infected pregnant women receiving cotrimoxazole (CTX) prophylaxis. This trial will be double blinded and will be carried out in Kenya, Tanzania and Mozambique. It will involve 1070 pregnant women that will be followed until the infant is 2 months old.
- Conditions
- Pregnancy, Malaria, HIV Infections
- Being tested
- Sulphadoxine-pyrimethamine, Mefloquine (full dose), Mefloquine (split dose), placebo, mefloquine
- Keywords
- Malaria, Pregnancy, HIV, Prevention, Malaria prevention
- Medical subject headings
- Malaria, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulphadoxine-pyrimethamineDrug
SP oral administration (500mg sulphadoxine and 25mg pyrimethamine) as IPTp at the 1st and 2nd Antenatal Clinic visit
Mefloquine (full dose)Drug
MQ oral administration (15 mg/Kg) on 1 day at the 1st and 2nd Antenatal Clinic visit as IPTp
Mefloquine (split dose)Drug
MQ oral administration (15 mg/kg) split dose over 2 days at the 1st and 2nd ANC visit as IPTp
placeboDrug
MQ-placebo oral administration at the 1st, 2nd and 3rd Antenatal Clinic visit as IPTp
mefloquineDrug
MQ oral administration (15 mg/Kg) at the 1st and 2nd Antenatal Clinic visit as IPTp
| Study group | Role | What they receive |
|---|---|---|
| Trial 1: IPTp-SP+LLITNs | Active comparator | HIV-negative pregnant women receiving 2 doses of IPTp (500mg of sulfadoxine and 25 mg of pyrimethamine) in the context of long lasting Insecticide Treated Nets (LLITNs) Receives: Drug: Sulphadoxine-pyrimethamine |
| Trial 1: IPTp-MQ (full dose) + LLITNs | Experimental | HIV-negative pregnant women receiving 2 full doses of IPTp (15 mg/Kg) in the context of long lasting Insecticide Treated Nets (LLITNs) Receives: Drug: Mefloquine (full dose) |
| Trial 1: IPTp-MQ (split dose)+LLITNs | Experimental | HIV-negative pregnant women receiving 2 doses of MQ as IPTp split dose over 2 days (15mg/kg) in the context of long lasting Insecticide Treated Nets (LLITNs Receives: Drug: Mefloquine (split dose) |
| Trial 2: CTX+IPTp-Placebo+LLITNs | Experimental | HIV-positive pregnant women receiving 3 doses of IPTp (placebo) in the context of long lasting Insecticide Treated Nets (LLITNs) Receives: Drug: placebo |
| Trial 2: CTX + IPTp-MQ+ LLITNs | Experimental | HIV-positive pregnant women receiving 3 doses of IPTp (15 mg/Kg) in the context of long lasting Insecticide Treated Nets (LLITNs) Receives: Drug: mefloquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trial 1 (IPTp MQ vs IPTp SP): Low birth weight.
Measured: day 0, birth
Trial 2 (CTX+IPTp MQ vs. CTX+IPTp placebo): Peripheral parasitaemia.
Measured: day 0, delivery
Secondary outcomes (2)
Trial 1: Prevalence of placental P. falciparum infection. Prevalence of moderate maternal anaemia at delivery.
Measured: day 0, delivery
Trial 2: Prevalence of placental P. falciparum infection. Prevalence of low birth weight babies (< 2500 g).
Measured: day 0, birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2008 (estimated)
- Study startSep 2009
- 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 (17)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5,820 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Barcelona Centre for International Health Research, Institute of Tropical Medicine, University of Tuebingen, Institut de Recherche pour le Developpement, Université d'Abomey-Calavi, Albert Schweitzer Hospital, Kenya Medical Research Institute, Ifakara Health Institute, Centro de Investigacao em Saude de Manhica, Vienna School of Clinical Research (VSCR), Austria., Centers for Disease Control and Prevention, Malaria in Pregnancy Consortium
- Investigators
- Clara Menendez, MD, PhD, Principal investigator, Barcelona Centre for International Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00811421
- Sponsor's protocol ID
- IP.07.31080.002
- Acronym
- MiPPAD
- Status last verified
- Mar 2014
- First submitted
- 18 Dec 2008
- Last updated
- 20 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Barry KM, Zoumenou R, Boivin MJ, Massougbodji A, Gonzalez R, Bodeau-Livinec F. Assessment of long-term mental health effects of mefloquine use during pregnancy: a secondary analysis of a randomized clinical trial in Benin. Travel Med Infect Dis. 2026 Jul-Aug;72:103006. doi: 10.1016/j.tmaid.2026.103006. Epub 2026 Jun 15.
PubMed 42297066Pons-Duran C, Wassenaar MJ, Yovo KE, Marin-Carballo C, Briand V, Gonzalez R. Intermittent preventive treatment regimens for malaria in HIV-positive pregnant women. Cochrane Database Syst Rev. 2024 Sep 26;9(9):CD006689. doi: 10.1002/14651858.CD006689.pub3.
PubMed 39324693Garrison A, Boivin MJ, Fievet N, Zoumenou R, Alao JM, Massougbodji A, Cot M, Bodeau-Livinec F. The Effects of Malaria in Pregnancy on Neurocognitive Development in Children at 1 and 6 Years of Age in Benin: A Prospective Mother-Child Cohort. Clin Infect Dis. 2022 Mar 9;74(5):766-775. doi: 10.1093/cid/ciab569.
PubMed 34297062Zoleko-Manego R, Mischlinger J, Dejon-Agobe JC, Basra A, Mackanga JR, Akerey Diop D, Adegnika AA, Agnandji ST, Lell B, Kremsner PG, Matsiegui PB, Gonzalez R, Menendez C, Ramharter M, Mombo-Ngoma G. Birth weight, growth, nutritional status and mortality of infants from Lambarene and Fougamou in Gabon in their first year of life. PLoS One. 2021 Feb 9;16(2):e0246694. doi: 10.1371/journal.pone.0246694. eCollection 2021.
PubMed 33561169Garrison A, Khoshnood B, Courtin D, Milet J, Garcia A, Massougbodji A, Ayotte P, Cot M, Bodeau-Livinec F. Blood lead level in infants and subsequent risk of malaria: A prospective cohort study in Benin, Sub-Saharan Africa. PLoS One. 2019 Jul 18;14(7):e0220023. doi: 10.1371/journal.pone.0220023. eCollection 2019.
PubMed 31318954Mireku MO, Davidson LL, Zoumenou R, Massougbodji A, Cot M, Bodeau-Livinec F. Consequences of prenatal geophagy for maternal prenatal health, risk of childhood geophagy and child psychomotor development. Trop Med Int Health. 2018 Aug;23(8):841-849. doi: 10.1111/tmi.13088. Epub 2018 Jun 22.
PubMed 29876999Moya-Alvarez V, Ouedraogo S, Accrombessi M, Cot M. High folate levels are not associated with increased malaria risk but with reduced anaemia rates in the context of high-dosed folate supplements and intermittent preventive treatment against malaria in pregnancy with sulphadoxine-pyrimethamine in Benin. Trop Med Int Health. 2018 Jun;23(6):582-588. doi: 10.1111/tmi.13064. Epub 2018 May 21.
PubMed 29683544Ndam NT, Mbuba E, Gonzalez R, Cistero P, Kariuki S, Sevene E, Ruperez M, Fonseca AM, Vala A, Maculuve S, Jimenez A, Quinto L, Ouma P, Ramharter M, Aponte JJ, Nhacolo A, Massougbodji A, Briand V, Kremsner PG, Mombo-Ngoma G, Desai M, Macete E, Cot M, Menendez C, Mayor A. Resisting and tolerating P. falciparum in pregnancy under different malaria transmission intensities. BMC Med. 2017 Jul 17;15(1):130. doi: 10.1186/s12916-017-0893-6.
PubMed 28712360Gonzalez R, Ruperez M, Sevene E, Vala A, Maculuve S, Bulo H, Nhacolo A, Mayor A, Aponte JJ, Macete E, Menendez C. Effects of HIV infection on maternal and neonatal health in southern Mozambique: A prospective cohort study after a decade of antiretroviral drugs roll out. PLoS One. 2017 Jun 2;12(6):e0178134. doi: 10.1371/journal.pone.0178134. eCollection 2017.
PubMed 28575010Mireku MO, Davidson LL, Boivin MJ, Zoumenou R, Massougbodji A, Cot M, Bodeau-Livinec F. Prenatal Iron Deficiency, Neonatal Ferritin, and Infant Cognitive Function. Pediatrics. 2016 Dec;138(6):e20161319. doi: 10.1542/peds.2016-1319. Epub 2016 Nov 17.
PubMed 27940685Mombo-Ngoma G, Mackanga JR, Gonzalez R, Ouedraogo S, Kakolwa MA, Manego RZ, Basra A, Ruperez M, Cot M, Kabanywany AM, Matsiegui PB, Agnandji ST, Vala A, Massougbodji A, Abdulla S, Adegnika AA, Sevene E, Macete E, Yazdanbakhsh M, Kremsner PG, Aponte JJ, Menendez C, Ramharter M. Young adolescent girls are at high risk for adverse pregnancy outcomes in sub-Saharan Africa: an observational multicountry study. BMJ Open. 2016 Jun 29;6(6):e011783. doi: 10.1136/bmjopen-2016-011783.
PubMed 27357200Bodeau-Livinec F, Glorennec P, Cot M, Dumas P, Durand S, Massougbodji A, Ayotte P, Le Bot B. Elevated Blood Lead Levels in Infants and Mothers in Benin and Potential Sources of Exposure. Int J Environ Res Public Health. 2016 Mar 11;13(3):316. doi: 10.3390/ijerph13030316.
PubMed 26978384Ruperez M, Gonzalez R, Mombo-Ngoma G, Kabanywanyi AM, Sevene E, Ouedraogo S, Kakolwa MA, Vala A, Accrombessi M, Briand V, Aponte JJ, Manego Zoleko R, Adegnika AA, Cot M, Kremsner PG, Massougbodji A, Abdulla S, Ramharter M, Macete E, Menendez C. Mortality, Morbidity, and Developmental Outcomes in Infants Born to Women Who Received Either Mefloquine or Sulfadoxine-Pyrimethamine as Intermittent Preventive Treatment of Malaria in Pregnancy: A Cohort Study. PLoS Med. 2016 Feb 23;13(2):e1001964. doi: 10.1371/journal.pmed.1001964. eCollection 2016 Feb.
PubMed 26905278Mireku MO, Davidson LL, Koura GK, Ouedraogo S, Boivin MJ, Xiong X, Accrombessi MM, Massougbodji A, Cot M, Bodeau-Livinec F. Prenatal Hemoglobin Levels and Early Cognitive and Motor Functions of One-Year-Old Children. Pediatrics. 2015 Jul;136(1):e76-83. doi: 10.1542/peds.2015-0491. Epub 2015 Jun 8.
PubMed 26055847Sicuri E, Fernandes S, Macete E, Gonzalez R, Mombo-Ngoma G, Massougbodgi A, Abdulla S, Kuwawenaruwa A, Katana A, Desai M, Cot M, Ramharter M, Kremsner P, Slustker L, Aponte J, Hanson K, Menendez C. Economic evaluation of an alternative drug to sulfadoxine-pyrimethamine as intermittent preventive treatment of malaria in pregnancy. PLoS One. 2015 Apr 27;10(4):e0125072. doi: 10.1371/journal.pone.0125072. eCollection 2015.
PubMed 25915616
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of Mefloquine as Intermittent Preventive Treatment of Malaria in Pregnancy
- ClinicalTrials.gov ID
- NCT00811421
- Acronym / sponsor ID
- MiPPAD / IP.07.31080.002
- Conditions
- Pregnancy, Malaria, HIV Infections
- Keywords
- Malaria, Pregnancy, HIV, Prevention, Malaria prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,820 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Barcelona Centre for International Health Research, Institute of Tropical Medicine, University of Tuebingen, Institut de Recherche pour le Developpement, Université d'Abomey-Calavi, Albert Schweitzer Hospital, Kenya Medical Research Institute, Ifakara Health Institute, Centro de Investigacao em Saude de Manhica, Vienna School of Clinical Research (VSCR), Austria., Centers for Disease Control and Prevention, Malaria in Pregnancy Consortium
- Study start
- Sep 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 19 Dec 2008 (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.
The study aims at comparing the safety, tolerability and efficacy of Mefloquine (MQ) to Sulfadoxine-Pyrimethamine (SP) as Interment Preventive Treatment in pregnancy (IPTp) for the prevention of malaria effects on the mother and her infant.
Detailed description
The current recommendation by the World Health Organization (WHO) to prevent malaria infection in pregnancy in areas of stable malaria transmission relies on:
- Prompt and effective case management of malaria illness
- The use of intermittent preventive treatment (IPTp) with at least 2 treatment doses of sulfadoxine-pyrimethamine (SP) and
- The use of insecticide treated nets (ITNs)
However, the spread of parasite resistance to SP, particularly in eastern Africa, and the significant overlap in some regions of malaria transmission and high prevalence of HIV infection, have raised concerns about the medium and long-term use of SP for IPTp.
HIV infection increases susceptibility to malaria and may reduce the efficacy of interventions. The evaluation of alternative antimalarials for IPTp is thus urgently needed also involving HIV infected women.
Of all the current available alternative antimalarial drugs, mefloquine (MQ) is the one that offers the most comparative advantages to SP.
A randomized multicenter trial will be conducted in 4 sites in Africa (Benin, Gabon, Tanzania and Mozambique) in order to compare the safety and efficacy of SP versus MQ as IPTp in the context of ITNs. In addition, MQ tolerability will be also evaluated by comparing the administration of MQ as a single intake with its administration as split dose in two days. In total 4716 pregnant women will be enrolled at the antenatal clinic (ANC) and will be followed until the infant is one year old.
Besides, in those countries where HIV prevalence in pregnant women is > 10%, MQ-IPTp will be compared to Placebo-IPTp in HIV infected pregnant women receiving cotrimoxazole (CTX) prophylaxis. This trial will be double blinded and will be carried out in Kenya, Tanzania and Mozambique. It will involve 1070 pregnant women that will be followed until the infant is 2 months old.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Trial 1: IPTp-SP+LLITNs | Active comparator | Drug: Sulphadoxine-pyrimethamineHIV-negative pregnant women receiving 2 doses of IPTp (500mg of sulfadoxine and 25 mg of pyrimethamine) in the context of long lasting Insecticide Treated Nets (LLITNs) |
| Trial 1: IPTp-MQ (full dose) + LLITNs | Experimental | Drug: Mefloquine (full dose)HIV-negative pregnant women receiving 2 full doses of IPTp (15 mg/Kg) in the context of long lasting Insecticide Treated Nets (LLITNs) |
| Trial 1: IPTp-MQ (split dose)+LLITNs | Experimental | Drug: Mefloquine (split dose)HIV-negative pregnant women receiving 2 doses of MQ as IPTp split dose over 2 days (15mg/kg) in the context of long lasting Insecticide Treated Nets (LLITNs |
| Trial 2: CTX+IPTp-Placebo+LLITNs | Experimental | Drug: placeboHIV-positive pregnant women receiving 3 doses of IPTp (placebo) in the context of long lasting Insecticide Treated Nets (LLITNs) |
| Trial 2: CTX + IPTp-MQ+ LLITNs | Experimental | Drug: mefloquineHIV-positive pregnant women receiving 3 doses of IPTp (15 mg/Kg) in the context of long lasting Insecticide Treated Nets (LLITNs) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Permanent resident in the area
- Gestational age at the first antenatal visit ≤ 28 weeks
- Signed informed consent
- Agreement to deliver in the study site's maternity(ies) wards
- Permanent resident in the area.
Key exclusion criteria (14 listed)
- Residence outside the study area or planning to move out in the following 18 months from enrollment
- Gestational age at the first antenatal visit > 28 weeks of pregnancy
- Known history of allergy to sulfa drugs or mefloquine
- Known history of severe renal, hepatic, psychiatric or neurological disease
- MQ or halofantrine treatment in the preceding 4 weeks
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 |
|---|---|---|
| Sulphadoxine-pyrimethamineSP oral administration (500mg sulphadoxine and 25mg pyrimethamine) as IPTp at the 1st and 2nd Antenatal Clinic visit | Drug | Trial 1: IPTp-SP+LLITNs |
| Mefloquine (full dose)MQ oral administration (15 mg/Kg) on 1 day at the 1st and 2nd Antenatal Clinic visit as IPTp | Drug | Trial 1: IPTp-MQ (full dose) + LLITNs |
| Mefloquine (split dose)MQ oral administration (15 mg/kg) split dose over 2 days at the 1st and 2nd ANC visit as IPTp | Drug | Trial 1: IPTp-MQ (split dose)+LLITNs |
| placeboMQ-placebo oral administration at the 1st, 2nd and 3rd Antenatal Clinic visit as IPTp | Drug | Trial 2: CTX+IPTp-Placebo+LLITNs |
| mefloquineMQ oral administration (15 mg/Kg) at the 1st and 2nd Antenatal Clinic visit as IPTp | Drug | Trial 2: CTX + IPTp-MQ+ LLITNs |
Primary outcome
Trial 1 (IPTp MQ vs IPTp SP): Low birth weight.
Time frame: day 0, birth
Trial 2 (CTX+IPTp MQ vs. CTX+IPTp placebo): Peripheral parasitaemia.
Time frame: day 0, delivery
2 secondary outcomes
Trial 1: Prevalence of placental P. falciparum infection. Prevalence of moderate maternal anaemia at delivery.
Time frame: day 0, delivery
Trial 2: Prevalence of placental P. falciparum infection. Prevalence of low birth weight babies (< 2500 g).
Time frame: day 0, birth
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 20 Mar 2014.
- Derived from this study: PubMed 42297066Barry KM, Zoumenou R, Boivin MJ, Massougbodji A, Gonzalez R, Bodeau-Livinec F. Assessment of long-term mental health effects of mefloquine use during pregnancy: a secondary analysis of a randomized clinical trial in Benin. Travel Med Infect Dis. 2026 Jul-Aug;72:103006. doi: 10.1016/j.tmaid.2026.103006. Epub 2026 Jun 15.
- Derived from this study: PubMed 39324693Pons-Duran C, Wassenaar MJ, Yovo KE, Marin-Carballo C, Briand V, Gonzalez R. Intermittent preventive treatment regimens for malaria in HIV-positive pregnant women. Cochrane Database Syst Rev. 2024 Sep 26;9(9):CD006689. doi: 10.1002/14651858.CD006689.pub3.
- Derived from this study: PubMed 34297062Garrison A, Boivin MJ, Fievet N, Zoumenou R, Alao JM, Massougbodji A, Cot M, Bodeau-Livinec F. The Effects of Malaria in Pregnancy on Neurocognitive Development in Children at 1 and 6 Years of Age in Benin: A Prospective Mother-Child Cohort. Clin Infect Dis. 2022 Mar 9;74(5):766-775. doi: 10.1093/cid/ciab569.
- Derived from this study: PubMed 33561169Zoleko-Manego R, Mischlinger J, Dejon-Agobe JC, Basra A, Mackanga JR, Akerey Diop D, Adegnika AA, Agnandji ST, Lell B, Kremsner PG, Matsiegui PB, Gonzalez R, Menendez C, Ramharter M, Mombo-Ngoma G. Birth weight, growth, nutritional status and mortality of infants from Lambarene and Fougamou in Gabon in their first year of life. PLoS One. 2021 Feb 9;16(2):e0246694. doi: 10.1371/journal.pone.0246694. eCollection 2021.
- Derived from this study: PubMed 31318954Garrison A, Khoshnood B, Courtin D, Milet J, Garcia A, Massougbodji A, Ayotte P, Cot M, Bodeau-Livinec F. Blood lead level in infants and subsequent risk of malaria: A prospective cohort study in Benin, Sub-Saharan Africa. PLoS One. 2019 Jul 18;14(7):e0220023. doi: 10.1371/journal.pone.0220023. eCollection 2019.
- Derived from this study: PubMed 29876999Mireku MO, Davidson LL, Zoumenou R, Massougbodji A, Cot M, Bodeau-Livinec F. Consequences of prenatal geophagy for maternal prenatal health, risk of childhood geophagy and child psychomotor development. Trop Med Int Health. 2018 Aug;23(8):841-849. doi: 10.1111/tmi.13088. Epub 2018 Jun 22.
- Derived from this study: PubMed 29683544Moya-Alvarez V, Ouedraogo S, Accrombessi M, Cot M. High folate levels are not associated with increased malaria risk but with reduced anaemia rates in the context of high-dosed folate supplements and intermittent preventive treatment against malaria in pregnancy with sulphadoxine-pyrimethamine in Benin. Trop Med Int Health. 2018 Jun;23(6):582-588. doi: 10.1111/tmi.13064. Epub 2018 May 21.
- Derived from this study: PubMed 28712360Ndam NT, Mbuba E, Gonzalez R, Cistero P, Kariuki S, Sevene E, Ruperez M, Fonseca AM, Vala A, Maculuve S, Jimenez A, Quinto L, Ouma P, Ramharter M, Aponte JJ, Nhacolo A, Massougbodji A, Briand V, Kremsner PG, Mombo-Ngoma G, Desai M, Macete E, Cot M, Menendez C, Mayor A. Resisting and tolerating P. falciparum in pregnancy under different malaria transmission intensities. BMC Med. 2017 Jul 17;15(1):130. doi: 10.1186/s12916-017-0893-6.
- Derived from this study: PubMed 28575010Gonzalez R, Ruperez M, Sevene E, Vala A, Maculuve S, Bulo H, Nhacolo A, Mayor A, Aponte JJ, Macete E, Menendez C. Effects of HIV infection on maternal and neonatal health in southern Mozambique: A prospective cohort study after a decade of antiretroviral drugs roll out. PLoS One. 2017 Jun 2;12(6):e0178134. doi: 10.1371/journal.pone.0178134. eCollection 2017.
- Derived from this study: PubMed 27940685Mireku MO, Davidson LL, Boivin MJ, Zoumenou R, Massougbodji A, Cot M, Bodeau-Livinec F. Prenatal Iron Deficiency, Neonatal Ferritin, and Infant Cognitive Function. Pediatrics. 2016 Dec;138(6):e20161319. doi: 10.1542/peds.2016-1319. Epub 2016 Nov 17.
- Derived from this study: PubMed 27357200Mombo-Ngoma G, Mackanga JR, Gonzalez R, Ouedraogo S, Kakolwa MA, Manego RZ, Basra A, Ruperez M, Cot M, Kabanywany AM, Matsiegui PB, Agnandji ST, Vala A, Massougbodji A, Abdulla S, Adegnika AA, Sevene E, Macete E, Yazdanbakhsh M, Kremsner PG, Aponte JJ, Menendez C, Ramharter M. Young adolescent girls are at high risk for adverse pregnancy outcomes in sub-Saharan Africa: an observational multicountry study. BMJ Open. 2016 Jun 29;6(6):e011783. doi: 10.1136/bmjopen-2016-011783.
- Derived from this study: PubMed 26978384Bodeau-Livinec F, Glorennec P, Cot M, Dumas P, Durand S, Massougbodji A, Ayotte P, Le Bot B. Elevated Blood Lead Levels in Infants and Mothers in Benin and Potential Sources of Exposure. Int J Environ Res Public Health. 2016 Mar 11;13(3):316. doi: 10.3390/ijerph13030316.
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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.
Clara Menendez, MD, PhD principal investigator
Barcelona Centre for International Health Research
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sulphadoxine-pyrimethamine, Mefloquine (full dose) and Mefloquine (split dose) in people with Pregnancy and Malaria, run by Hospital Clinic of Barcelona at 5 sites in 5 countries.
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 12 inclusion and 14 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 20 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Benin, Gabon, Kenya, Mozambique, Tanzania. 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.
What does the primary outcome measure?
Trial 1 (IPTp MQ vs IPTp SP): Low birth weight. (time frame: day 0, birth). The study lists 2 primary outcomes in all. 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 NCT00811421, which also lists 17 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 20 Mar 2014.