Safe and Efficacious Artemisinin-based Combination Treatments for African Pregnant Women With Malaria

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR201008000248160
• Date of registration: 17/08/2010
• Primary sponsor: Institute of Tropical Medicine
• Public title: Safe and Efficacious Artemisinin-based Combination Treatments for African Pregnant Women With Malaria
• Scientific title: Safe and Efficacious Artemisinin-based Combination Treatments for African Pregnant Women With Malaria
• Date of first enrolment: 2010-06-11
• Target sample size: 3480
• Recruitment status: Open to recruitment: actively recruiting participa
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201008000248160
• Study type: interventional
• Study design: Parallel: different groups receive different interventions at same time during study,; Randomised,; Simple randomisation using a radomisation table created by a computer software program ,; Sealed opaque envelopes ,

Countries of recruitment

South Africa

Contacts

• Name: Umberto D'Alessandro
• Affiliation: Parasitology unit, parasite epidemiology and control

• Name: Umberto D'Alessandro
• Affiliation: Parasitology unit, parasite epidemiology and control

Key inclusion & exclusion criteria

Inclusion criteria: 1. gestation b= 16 weeks and ` 37 weeks (women should not be included one week before the expected date of delivery)
2. P. falciparum monoinfection of any density, with or without symptoms
3. Hb b= 7 g/dL
4. At least 15 years old
5. Residence within the health facility cathment's area
6. willing to deliver at the health facility
7. willing to adhere to the study requirements (including, in Zambia and Malawi, HIV voluntary counseling and testing)
8. ability to provide written informed consent; if the woman is minor of age ot emancipated, the consent must be given by a parent or legal guardian according to national law (however, in this case, also the minor woman will sign the consent form, to document that she is freely giving her assent to take part in the study)
Exclusion criteria: 1. history of allergic reactions to the study drugs
2. history of known pregnancy complications or bad obstretic history such as repeated stillbirht or eclampsia
3. history of presence of major ilnesses likely to influence the pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis
4. current cotrimoxazole prohylaxis or ARV treatment
5. any significant illness at the time of screening that requires hospitalization, including severe malaria
6. intent to move out of the study cathment's area before delivery or deliver at relative's home out of the cathment's area
7. prior enrolment in the study or concurrent enrolment in another study
8. unable to take oral medication
9. clear evidence of recent (1 week) treatment with antimicrobials with antimalarial activity (clindamycin; azythromycin; etc.)

Age minimum: 15 Year
Age maximum: 60 Year
Gender: Female

Health Condition(s) or Problem(s) studied

Malaria
and pregnancy

Primary Outcome(s)

Safety profiles including significant changes in relevant laboratory values

Treatment failure (PCR adjusted)

Secondary Outcome(s)

Asexual parasite clearance time

Determination of the PK profile of MQ, AQ and PQ (on 120 women/treatment)

Gametocytaemia (prevalence and density)

Gametocyte carriage (gametocyte - weeks)

Haemoglobin changes

In vitro and search of molecular markers related to drug resistance

Mean birth weight and prevlance of low birth weight newborns

PCR unadjusted treatment failure

The presence of acute, chronic or past infection of the placenta (prevalence)

Time to failure

Secondary ID(s)

ITMP0308

NCT00852423

Source(s) of Monetary Support

EDCTP