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Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za     Website: www.pactr.org

Trial no.: PACTR201211000451437 Date registered: 2012/11/06
TRIAL DESCRIPTION
Public title PK_AL_PREGNANCY_KENYA
Official 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
Brief summary describing the background
and objectives of the trial
ACTs are used as first line treatment for uncomplicated malaria in 2nd and 3rd trimesters but data is insufficient to determine if dosing extrapolated from non-pregnant populations is adequate. The main objective is to describe the population pharmacokinetics of artemether-lumefantrine used in the treatment of uncomplicated malaria in pregnant women compared with non-pregnant women in Kenya. The secondary objective is to determine day 28 treatment outcomes in relation to pharmacokinetics.
Type of trial Others
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Malaria ,
Purpose of the trial Treatment
Anticipated trial start date 2013-01-28
Actual trial start date
Anticipated date of last follow up 2013-09-30
Actual date of last follow up
Anticipated target sample size (number of participants) 75   
Actual target sample size (number of participants)   
Recruitment status Not yet recruiting
Secondary Ids Issuing authority/Trial register Links to Secondary ID
SSC 2416 KEMRI Scientific Steering Committee

STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person
allocating the participants to the intervention arms
Masking If masking / blinding was used
Single group: all participants receive same intervention throughout study Non-randomised Open-label (masking not used)

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group artemether-lumefantrine 80mg artemether and 480mg lumefantrine at hours 0, 8, 24, 36, 48 and 60 3 days Oral treatment for uncomplicated malaria 75

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
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 / µl 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 1. Severe and/or complicated malaria including severe anaemia (Hb <8 g/dl) and hyper-parasitaemia (>200,000 ¿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 18 Years 49 Years Female

ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes 2012/12/03 KEMRI Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Mbagathi Road Nairobi 00200 Kenya

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pharmacokinetics of artemether-lumefantrine 0 minutes 30 minutes 60 minutes 90 minutes 2 hours 3 hours 4 hours 6 hours 8 hours 12 hours 24 hours 30 hours 52 hours 66 hours 84 hours Day 7 Day 14

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ombeyi Health Centre Kisumu-Chemelil Road Kisumu 40100 Kenya
Ahero Sub-District Hospital Kericho-Kisumu Road B1 Ahero 40101 Kenya

FUNDING SOURCES
Name of source Street address City Postal code Country
Consortium for National Health Research Lenana Road Nairobi 00202 Kenya

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kenya Medical Research Institute Mbagathi Way Nairobi 00200 Kenya University

COLLABORATORS
Name Street address City Postal code Country
Strathmore University Ole Sangale Road Nairobi 00200 Kenya

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Dr Elizabeth Juma jumaelizabeth@yahoo.com +254722796494 +254202720030
Street address City Postal code Country Position / Affiliation
Mbagathi Road Nairobi 00200 Kenya Senior Research Officer
Role Name Email Phone Fax
Scientific Enquiries Dr Bernhards Ogutu ogutu6@gmail.com +254733966065 +254202720030
Street address City Postal code Country Position / Affiliation
Mbagathi Road Nairobi 00200 Kenya Principal Research Officer
Role Name Email Phone Fax
Public Enquiries Dr Kevin Omondi kevinoomondi@gmail.com +254202722541 +254202720030
Street address City Postal code Country Position / Affiliation
Kericho-Kisumu Road Ahero 40101 Kenya Clinical Trial Coordinator