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.: PACTR201402000684137 Date of Approval: 21/10/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Treatment Efficacy Study
Official scientific title The efficacy of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in the Gambia: 2013 follow up study
Brief summary describing the background and objectives of the trial The overall goal of this study is to monitor the therapeutic efficacy of artemether-lumefantrine (AL) for the treatment of uncomplicated P. falciparum malaria in west coast region of The Gambia. A total of 120 children with clinically diagnosed uncomplicated p. falciparum malaria will be enrolled from two health centres, treated with AL and followed up for 28 days for clinical and parasitological response.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) TES 2
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 12/09/2013
Actual trial start date 17/09/2013
Anticipated date of last follow up 31/12/2013
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
SCC 1348
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 tablets 1 - 4 tablets depending on weight twice a day for 3 days 120
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age above 1 year to 12 years 2. Mono-infection with P. falciparum determined by microscopy 3. Parasite density between 1000 and 100,000/µl asexual forms 4. Axillary temperature ¿ 37.5 °C and/or history of fever during the past 24 hours 5. Ability to swallow oral medication 6. Ability and willingness to comply with the study protocol; resident in the study area for the duration of the study and willing to come for all scheduled study visits 7. Informed consent from the caregiver (parent or guardian). 1.Danger signs or signs of severe falciparum malaria based on standard WHO 2.Mixed infection with Plasmodium species other than falciparum determined by microscopy. 3.Severe malnutrition defined by a very low weight for age (below -3z scores of the median WHO growth standards), by visible severe wasting, or by the presence of nutritional oedema. 4.Other identifiable cause for the fever (e.g. measles, acute respiratory tract infection) 5.Long term regular medication, which may interfere with antimalarial pharmacokinetics; such as for TB, HIV, cardiac disease. 6.History of hypersensitivity or contraindications to any component of the medicine being tested. 1 Year(s) 12 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 31/07/2013 The Gambia Government/MRC Joint Ethics committee
Ethics Committee Address
Street address City Postal code Country
c/o MRC, Fajara Near Banjul Gambia
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 31/07/2013 The Gambia Government/MRC Joint Ethics committee
Ethics Committee Address
Street address City Postal code Country
c/o MRC, Fajara Near Banjul Gambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Parassite clearance time measured between day 0 and day 2
Primary Outcome Parassite clearance time measured between day 0 and day 2
Primary Outcome 1. The proportion of children with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy Between Day 0 and day 28
Primary Outcome 3. Ex-vivo susceptibility of parasites to ACT partner drugs Day 0
Primary Outcome 3. Ex-vivo susceptibility of parasites to ACT partner drugs Any other day post Day 3 when recurrent parasitemia >1000 parasites / µl is detected
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Brikama Health Centre Brikama Kombo Central Gambia
Jammeh Foundation For Peace Hopsital Bundung Banjul Gambia
FUNDING SOURCES
Name of source Street address City Postal code Country
European and Developing Countries Clinical Trials Partnership Laan van Nieuw Oost Indie 300 Den Haag 2593 CE Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Medical Research Council Unit Atlantic Road, Fajara Near Banjul Gambia Hospital
COLLABORATORS
Name Street address City Postal code Country
National Malaria Control Program Kanifing Banjul Gambia
Ministry of Health & Social Welfare The Quadrangle Banjul Gambia
National Public Health Laboratories Bertil Harding Highway Kotu Gambia
National Pharmaceutical Services Kotu Gambia
National Pharmaceutical Services Bertil Harding Highway Kotu Gambia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Umberto D'Alessandro udalessandro@mrc.gm +220 449 54 42/6 Ext: 4001 MRC, Atlantic Road
City Postal code Country Position/Affiliation
Fajara, Near Banjul Gambia
Role Name Email Phone Street address
Public Enquiries Marie Rose Thorpe mthorpe@mrc.gm +220 4495442/6 Ext: 4410 Atlantic Road
City Postal code Country Position/Affiliation
Fajara, Near Banjul Gambia Project Administrator
Role Name Email Phone Street address
Scientific Enquiries Abdullahi Ahmad aahmad@mrc.gm +220-4495442-6 MRC, Atlantic Road
City Postal code Country Position/Affiliation
Fajara, Near Banjul Gambia Study Co-ordinator
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information