Malaria in pregnancy Infections and Infestations Malaria
Conditions
Interventions
Group 1: Artesunate 50 mg tablets (2 mg/kg/day) for seven days
Group 2: Co-artemether (20/120 mg artemether/lumefantrine) four tablets twice a day for three days with 200 ml of chocolate milk at each
Sponsors
UNICEF/UNDP/World Bank/WHO - Special Programme for Research and Training in Tropical Diseases (TDR)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Pregnant women with uncomplicated falciparum or mixed infection (i.e. Plasmodium falciparum and Plasmodium vivax), symptomatic or not, in the second or third trimester, who have failed after a course of quinine for seven days 2. Willing and able to participate and comply with the study protocol 3. Attend the Shoklo Malaria Research Unit (SMRU) AnteNatal Clinics (ANCs) regularly 4. Agree to deliver at SMRU
Exclusion criteria
Exclusion criteria: 1. Splenectomy 2. A known chronic disease (cardiac, renal, hepatic) 3. Known haemoglobinopathy 4. Known hepatic or renal impairment 5. Inability to follow the ANC consultation 6. History of alcohol or narcotic abuse 7. Inability to tolerate oral treatment 8. Severe and complicated malaria 9. Known hypersensitivity to artemisinin derivatives 10. Patient taking any drug inhibiting the cytochrome enzyme CYP3A4 or drug which is metabolised by cytochrome enzyme CYPD or family 11. History of sudden death or of prolongation of QTc interval on electrocardiogram (ECG) 12. Patients with cardiac arrythmia, Congestive Cardiac Failure (CCF), or bradycardia accompanied by reduced left ventricular function 13. Intake of drugs that prolong QTc interval
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Other outcomes include: 1. Gametocyte carriage 2. Pharmacokinetic parameters including the plasma lumefantrine levels at day seven as a marker of absorption as well as the infant development during the first year of life 3. The histo-pathology examination (presence of parasites, pigments, monocytes infiltrations and other placental changes) of the placenta | — |
Primary
| Measure | Time frame |
|---|---|
| Polymerase Chain Reaction (PCR) adjusted parasitological cure, at day 42 or at delivery depending on which occurs last. | — |
Countries
Thailand
Outcome results
None listed