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.: PACTR201209000419241 Date of Approval: 25/09/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A study comparing the efficacy of clindamycin plus quinine with coartem for treating Kenyan children with uncomplicated falciparum malaria
Official scientific title An open-label randomized controlled trial of the efficacy and safety of clindamycin plus quinine compared with artemether-lumefantrine for the treatment of children with uncomplicated falciparum malaria in western Kenya
Brief summary describing the background and objectives of the trial Clindamycin plus quinine is recommended by World Health Organization as a non-artemisinin-based antimalarial drug based on consensus opinion. The evidence on the efficacy of clindamycin plus quinine compared with other antimalarial drugs including artemether-lumefantrine is scanty. We propose to evaluate the therapeutic efficacy and safety of clindamycin plus quinine compared with artemether-lumefantrine in the treatment of children with uncomplicated falciparum malaria in western Kenya.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CLINDAQUINE
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 01/11/2012
Actual trial start date 11/03/2014
Anticipated date of last follow up 30/04/2014
Actual Last follow-up date 03/12/2014
Anticipated target sample size (number of participants) 384
Actual target sample size (number of participants) 384
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
KEMRI SSC No 2357
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 permuted block randomisation Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Clindamycin 10mg per kg every 12 hours 3 days paediatric flavoured granules for oral susspension 192
Experimental Group Quinine 10mg per kg every 12 hours 3 days quinine tablets 192
Control Group Artemether-lumefantrine every 12 hours 3 days tablets 192 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age 6-59 months 2. Axillary temperature equal to or above 37.5ยบ C or history of fever in the past 48 hours 3. Body weight above 5.0 kg 4. Slide-confirmed infection with P. falciparum 5. Parasitaemia 2,000-200,000 asexual forms per microlitre 6. Parent/guardian provides informed consent 1. Presence of general danger signs or other signs of severe malaria and complicated falciparum malaria according to current WHO definitions. 2. Mixed or mono-infection with another Plasmodium species. 3. Presence of severe malnutrition, defined as weight-for-age below 3 standard deviations below the mean (NCHS/WHO normalized reference values). 4. Known hypersensitivity to any of the drugs being tested. 5. Presence of febrile conditions caused by diseases other than malaria. 6. Presence of other serious or chronic medical conditions (heart failure, sickle cell disease). 7. Plan to travel or leave the area within the next 3 months 8. Inability to swallow oral medication 9. Residence beyond 10km of the catchment area of the study hospital. 6 Month(s) 59 Month(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 KEMRI Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
KEMRI, P.O. Box 54840, Off Mbagathi Road NAIROBI 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cure rate Day 28 after starting treatment
Secondary Outcome Fever resolution rate 0, 6, 12, 18, 24, 36, 42, 48, 54, 60, 66 and 72 hours after starting treatment
Secondary Outcome parasite clearance rate 0, 12, 24, 36, 48, 60, 72 hours after staring treatment
Secondary Outcome gametocyte carriage Day 0, 3, 7, 14, 21 and 28 after starting treatment
Secondary Outcome haemoglobin Day 0, 3, 7, 14, 21 and 28 after starting treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ahero sub-District Hospital Kericho-Kisumu road Kisumu 40100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP P.O. Box 93015, 2509 AA Laan van Nieuw Oost Indie 334 Hague 2593CE Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kenya Medical Research Institute P.O. Box 54840, Off Mbagathi Road NAIROBI 00200 Kenya Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Bernhards Ogutu P.O. Box 54 Kisumu 40100 Kenya
Elizabeth Juma P.O. Box 1578 Kisumu 40100 Kenya
John Logedi P.O. Box 4882 Nairobi 00200 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Charles Obonyo cobonyo65@yahoo.com +254 724993118 P.o. Box 1578
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Principal Research Officer, KEMRI
Role Name Email Phone Street address
Public Enquiries John Vulule JVulule@yahoo.com +254 722679547 P.O. Box 1578
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Centre Director, KEMRI Kisumu
Role Name Email Phone Street address
Scientific Enquiries Charles Obonyo cobonyo65@yahoo.com +254 724993118 P.O. Box 1578
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Scientist, KEMRI
REPORTING
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