Status:
COMPLETED
A Trial of Antimalarial Drugs Used in Pregnancy in Tanzania
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborating Sponsors:
National Institute for Medical Research, Tanzania
Conditions:
Malaria
Eligibility:
FEMALE
15-38 years
Phase:
PHASE3
Brief Summary
Pregnant women are vulnerable to malaria, with significant implications both for their health and for the pregnancy. Sulfadoxine-pyrimethamine (SP) is currently the first line drug for the treatment o...
Detailed Description
The objectives of this study are to assess the therapeutic efficacy and safety of SP as the current first line drug, and three other potential alternative combinations in treating uncomplicated falcip...
Eligibility Criteria
Inclusion
- A pregnant woman who has either a positive blood smear for P.falciparum with at least 1000 asexual parasites/uL in an asymptomatic woman
- or any of the following symptoms within 2 days prior to consultation:
- history of fever;
- headache,
- vomiting,
- chills/rigors,
- and/or any of the following signs: temperature \>37.50C and \<39.50C, Hb\>5 and \<9 g/dl together with P.falciparum parasitaemia at any density
- and (in both cases) the following:
- Has no exclusion criterion (see below);
- Is 14-34 weeks pregnant on the day of attending the ANC clinic or OPD;
- Has a viable foetus, defined by presence of foetal heartbeat by sonicaid or pinnard (foetal heartbeat is not heard until 14 weeks);
- Is able to take study drugs by the oral route;
- Is able to attend stipulated days for follow up clinic and provide specimens;
- Gives informed written or witnessed verbal consent to participate by herself, and also through her parent/guardian if aged \<15 years (in conformity to Tanzania Law).
Exclusion
- Severe and complicated forms of malaria (as defined by WHO, 1996);
- Pregnancy in the first trimester;
- A mixed plasmodial infection;
- Complicated pregnancy, e.g. signs/symptoms of toxaemia of pregnancy;
- 23 or more abortions or stillbirths;
- Presence of concomitant disease masking assessment of the response to treatment ;
- An intake of drugs contraindicated in pregnancy, e.g. tetracycline, cotrimoxazole or a macrolide antibiotic;
- An intake of drugs with effective antimalarial activity within the last 2 weeks.
- Significantly abnormal baseline haematology (except anaemia) or clinical chemistry parameters, e.g. laboratory evidence of renal impairment (serum creatinine \>2 mg/dl) or of hepatitis (alanine aminotransferase \[ALT\] \>5 times upper limit of normal);
- Previous participation in the study: Women having a second episode of malaria after completing the 28-day follow up will have details recorded and offered quinine but not be re-enrolled.
- Multiple gestation pregnancies, eg twins
- Mother aged 38 years or above
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT00146731
Start Date
January 1 2004
End Date
September 1 2007
Last Update
January 12 2017
Active Locations (1)
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1
Muheza Designated District Hospital
Muheza, Tanga, Tanzania, PB