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.: PACTR201411000937373 Date of Approval: 10/11/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Safety of single low dose primaquine in Senegal.
Official scientific title A trial of the safety of low dose primaquine in addition to ACTs commonly used in Senegal.
Brief summary describing the background and objectives of the trial The substantial progress made in the fight against malaria these last years, have encouraged many malaria endemic countries to outline the vision of malaria elimination. The feasibility of malaria elimination will depend on transmission intensity among other factors. Implementation of additional antimalarial interventions aiming at reducing malaria transmission intensity is thus needed to reach the malaria elimination goal. The use of primaquine, an 8-aminoquinoline, can contribute to interrupt transmission, as this drug can reduce gametocyte carriage of Plasmodium falciparum. WHO recommends the addition of a single low-dose of primaquine (0.25 mg base/kg) to artemisinin combination treatments (ACTs) as a gametocytocidal medicine for P. falciparum, particularly as a component of pre-elimination or elimination programs. However, primaquine has been scarcely used in Africa and there are still concerns about its safety as the drug can cause acute haemolytic anaemia in individuals with G6PD deficiency. Safety studies are thus needed in African countries to guide the implementation of low-dose primaquine. The aim of this study is to assess the safety and the potential benefit of adding primaquine to ACT treatment in Senegal.
Type of trial RCT
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 03/11/2014
Actual trial start date 15/11/2014
Anticipated date of last follow up 28/02/2015
Actual Last follow-up date 28/02/2015
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants) 300
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
Protocole SEN 13/65 Conseil National d'Ethique et de Recherche en Santé (CNERS) - Senegal.
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 Computer based randomisation with permuted block of 12 Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ACT plus primaquine group ACT treatment: 1 dose per day . Primaquine: single low dose (0.25 mg/kg) at day 1 ACT: 3 days. Primaquine: 1 day. Standard malaria treatment combined with a transmission blocking drug (primaquine). 150 Active-Treatment of Control Group
Control Group ACT treatment Group 1 Daily dose 3 days Standard malaria treatment 150 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Adult patients with acute uncomplicated P. falciparum malaria; 2. P. falciparum monospecific infection with parasite density ranged from 1000 to 100 000 trophozoite/¿L. 3. Willingness to participate in the planed study investigations and to remain in the study area for the duration of the study; 4. Participants informed consent; 5. Absence of known chronic illness such as hypertension, diabetes, renal and liver disease. 1. Known allergy to the study medications; 2. Presence of severe anaemia (haemoglobin < 8 g/dl) at enrolment; 3. Pregnancy, or breastfeeding. 20 Year(s) 50 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 23/05/2014 Conseil National d'Ethique pour la Recherche en Santé
Ethics Committee Address
Street address City Postal code Country
Ministére de la Santé du Sénégal, Rue Aimée Césaire Dakar Fann. Dakar Senegal
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean haemoglobin difference from day 0 to day 7 after treatment with ACT and primaquine. - At enrollment (day0). - Day 7 after patient enrollment.
Secondary Outcome Mean haemoglobin level at day 14 of follow up in each treatment arm. - At enrollment. - At day 14 after patient enrollment.
Secondary Outcome Mean haemoglobin level at day 28 of follow up in each treatment arm. - At enrollment (day 0). - At day 28 after patient enrollment.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Deggo Health post Medical District of Pikine Dakar Senegal
FUNDING SOURCES
Name of source Street address City Postal code Country
Malaria Capacity Development Consortium (MCDC) - London School of Hygiene and Tropical Medecine. Keppel Street London London WC1E 7HT United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University Cheikh Anta DIOP of Dakar, Department of Medical Parasitology. Avenue Cheikh Anta DIOP Dakar 5005 Dakar - Fann Senegal University
COLLABORATORS
Name Street address City Postal code Country
London School of Hygiene and Tropical Medecine. Keppel Street London WC1E 7HT United Kingdom
Malaria Elimination Initiative Global Health Group. UCSF Global Health Sciences 50 Beale St, 12th Floor San Francisco, CA 94105, USA. San Francisco United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Roger TINE roger.tine@ucad.edu.sn 00 221 77 637 05 31 University Cheikh Anta DIOP of Dakar, Department of Medical Parasitology.
City Postal code Country Position/Affiliation
Dakar 5005 Senegal Professor of Medical Parasitology
Role Name Email Phone Street address
Public Enquiries Samba Cor Sarr bathie65@yahoo.fr 00 221 77 647 09 99 Conseil National d'Ethique pour la Recherche en Santé, Ministére de la Santé du Sénégal.
City Postal code Country Position/Affiliation
Dakar Senegal Head of National ethical Committee
Role Name Email Phone Street address
Scientific Enquiries Khadime SYLLA khadimesylla@yahoo.fr 00 221 77 521 76 44 University Cheikh Anta DIOP of Dakar, Department of Medical Parasitology.
City Postal code Country Position/Affiliation
Dakar 5005 Senegal Lecturer in Medical Parasitology
REPORTING
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