Evaluation of Alternative Antimalarial Drugs for Malaria in Pregnancy
Information source: Hospital Clinic of Barcelona
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pregnancy; Malaria; HIV Infections
Intervention: Sulphadoxine-pyrimethamine (Drug); Mefloquine (full dose) (Drug); Mefloquine (split dose) (Drug); placebo (Drug); mefloquine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Hospital Clinic of Barcelona Official(s) and/or principal investigator(s):
Clara Menendez, MD, PhD, Principal Investigator, Affiliation: Barcelona Centre for International Health Research
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.
Clinical Details
Official title: Evaluation of the Safety and Efficacy of Mefloquine as Intermittent Preventive Treatment of Malaria in Pregnancy
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: Trial 1 (IPTp MQ vs IPTp SP): Low birth weight.Trial 2 (CTX+IPTp MQ vs. CTX+IPTp placebo): Peripheral parasitaemia.
Secondary outcome: Trial 1: Prevalence of placental P. falciparum infection. Prevalence of moderate maternal anaemia at delivery.Trial 2: Prevalence of placental P. falciparum infection. Prevalence of low birth weight babies (< 2500 g).
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
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:
- 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.
Exclusion Criteria:
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
- 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
Locations and Contacts
Faculté des Sciences de la Santé (FSS), Université d'Abomey Calavi, Allada, Benin
Medical Rsearch Unit (MRU), Albert Schweitzer Hospital, Lambaréné, Gabon
Kenya Medical Research Institute (KEMRI)/ CDC, Kisumu, Kenya
Ifakara Health Institute (IHI), Dodoma, Tanzania
Centro de Investigaçao em Saúde da Manhiça (CISM), Manhiça, Maputo, Mozambique
Additional Information
Starting date: September 2009
Last updated: March 19, 2014
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