PK_AL_PREGNANCY_KENYA

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR201211000451437
• Date of registration: 06/11/2012
• Primary sponsor: Kenya Medical Research Institute
• Public title: PK_AL_PREGNANCY_KENYA
• Scientific title: An open label clinical trial of the pharmacokinetics of artemether-lumefantrine in pregnant and non-pregnant women with uncomplicated plasmodium falciparum malaria in Kenya
• Date of first enrolment: 2013-01-28
• Target sample size: 75
• Recruitment status: Not yet recruiting
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201211000451437
• Study type: interventional
• Study design: Single group: all participants receive same intervention throughout study,; Non-randomised,

Countries of recruitment

South Africa

Contacts

• Name: Kevin Omondi
• Affiliation: Clinical Trial Coordinator

• Name: Bernhards Ogutu
• Affiliation: Principal Research Officer

Key inclusion & exclusion criteria

Inclusion criteria: 1. Pregnancy in the second or third trimester or non-pregnant females aged 18 to 40 years
2. Able to provide informed consent
3. Presence of fever (Temp ? 37.5?C) or a history of fever in the previous 2 days
4. Presence of asexual P. falciparum monoinfection or mixed infection with P. falciparum as the predominant infection
5. Initial parasite density of between 1000 and 200,000 asexual parasites / ?l of blood
6. Not suffering from severe and complicated forms of malaria
7. Haemoglobin ? 8g/dl
8. Able to take drugs under study by the oral route

Exclusion criteria: 1. Severe and/or complicated malaria including severe anaemia (Hb `8 g/dl) and hyper-parasitaemia (b200,000 ?l)
2. Patients treated with mefloquine, halofantrine within the 7 days before D0 (Day 0) or with quinine salts and artemisinin derivatives within 3 days before Day 0, or artemether-lumefantrine 30 days before Day 0.
3. Patients who require intensive care for malaria or another severe concomitant illness capable of interfering with the clinical evolution of malaria
4. Patients with vomiting and/or diarrhoea
5. Patients with known history of heart disease or arrhythmia
6. Patients taking concomitant medication that may interfere with study endpoints (see
7. History of allergy to artemether/lumefantrine or quinine


Age minimum: 18 Year
Age maximum: 49 Year
Gender: Female

Health Condition(s) or Problem(s) studied

Malaria
null

Primary Outcome(s)

Pharmacokinetics of artemether-lumefantrine

Secondary ID(s)

SSC 2416

Source(s) of Monetary Support

Consortium for National Health Research