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: pactr.samrc.ac.za
Trial no.: PACTR201211000451437 Date of Approval: 06/11/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
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 CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Treatment: Other
Anticipated trial start date 28/01/2013
Actual trial start date 01/08/2013
Anticipated date of last follow up 30/09/2013
Actual Last follow-up date 29/04/2014
Anticipated target sample size (number of participants) 75
Actual target sample size (number of participants) 75
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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
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 Age Category Minimum age Maximum 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 Year(s) 49 Year(s) 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 03/12/2012 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
Ahero Sub-District Hospital Kericho-Kisumu Road B1 Ahero 40101 Kenya
Ombeyi Health Centre Kisumu-Chemelil Road Kisumu 40100 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 Street address
Principal Investigator Elizabeth Juma jumaelizabeth@yahoo.com +254722796494 Mbagathi Road
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya Senior Research Officer
Role Name Email Phone Street address
Public Enquiries Kevin Omondi kevinoomondi@gmail.com +254202722541 Kericho-Kisumu Road
City Postal code Country Position/Affiliation
Ahero 40101 Kenya Clinical Trial Coordinator
Role Name Email Phone Street address
Scientific Enquiries Bernhards Ogutu ogutu6@gmail.com +254733966065 Mbagathi Road
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya Principal Research Officer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information