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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201111000316370 Date of Registration: 07/09/2011
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title ACT SENSITIVITY SURVEILLANCE IN KENYA [retrospectively registered]
Official scientific title An open-label randomized study evaluating the efficacies of artemether-lumefantrine (ART/LUM®) and dihydroartemisinin/piperaquine in the treatment of uncomplicated Plasmodium falciparum malaria in children under five years of age under different epidemiological settings in Kenya
Brief summary describing the background and objectives of the trial Kenya launched the artemether/lumfantrine (ART/LUM®) as the first line treatment for uncomplicated malaria in 2006. However, the second line treatment has remained monotherapy using quinine. The international community and WHO recommend that countries replace monotherapy with combinations of drugs that include artemisinin derivatives. There is also need to continuously monitor the efficacy of the first line. This study is aimed at evaluating the efficacy of 2 artemisinin based combination ther
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Paediatrics
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/03/2010
Actual trial start date 08/04/2010
Anticipated date of last follow up 27/04/2011
Actual Last follow-up date
Anticipated target sample size (number of participants) 466
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
SSC 1682 KENYA MEDICAL RESEARCH INSTITUTE ETHICS 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
Parallel: different groups receive different interventions at same time during study Randomised Used random tables Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group artemether/lumefantrine Number of tablets based on weight band twice daily 3 days Antimalarial 233
Control Group Dihydroartemisinin/Piperaquine once daily based on weight 3 days This is the second line treatment for uncomplicated malaria 233 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Presentation to the Health facility with probable clinical malaria. 2. Presence of fever ¿ 37.50C (axillary) 3. Aged between 6 and 59 months, inclusive 4. Weight ¿ 5 kgs 5. Mono-infection with P.falciparum at an asexual parasite density of 1000 ¿ 200,000 parasites per ¿l in malaria 6. Not suffering from severe and complicated forms of malaria (according to WHO, 2000 classification) 7. Able to take drugs under study by the oral route 8. Parent or guardian gives an informed written consent to participate in study 1. Severe and/or complicated malaria (WHO, 2000 classification), including severe anaemia (Hb ¿5 g/dl), two or more seizures in last 24 hrs and hyper-parasitaemia (parasites >200,000 ¿l). 2. General clinical condition calling for hospitalization 3. Evidence of concomitant infections/disease at the time of presentation 4. Past or present history of chronic illnesses or any other underlying illness that would compromise the diagnosis and evaluation of the response to the study drug 5. History of allergy to artemisinin, lumefantrine or piperaquine 6. Full treatment with other antimalarial drugs within the past 14 days 6 Month(s) 59 Year(s) Both
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 20/11/2009 KEMRI
Ethics Committee Address
Street address City Postal code Country
Mbagathi Nairobi 0200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The risk of PCR corrected parasitaemia following treatment Day 7 Day 14 Day 28 Day 42
Secondary Outcome Adequate clinical and parasitological response (ACPR): Day 7 Day 14 Day 28 Day 42
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ombeyi Dispensary Ahero-Ombey road Kisumu 40100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Ministry of Public Health and Sanitation Cathedral Road Nairobi 0200 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Kenya Medical Research Institute Mbagathi Road Nairobi 0200 Kenya University
COLLABORATORS
Name Street address City Postal code Country
Kenya Medical Research Institute Mbagathi Nairobi 0200 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bernhards Ogutu ogutu6@gmail.com +254733966065 Mwingi Road
City Postal code Country Position/Affiliation
Nairobi 0202 Kenya Chief Research Officer
Role Name Email Phone Street address
Public Enquiries John Ongecha michaelongecha@yahoo.com +254733447920 Busia road
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Senior Research Officer
Role Name Email Phone Street address
Scientific Enquiries Kevin Omondi Onyango kevinoomondi@gmail.com 254732740654 Busia road
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Senior 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