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.: PACTR201905899965726 Date of Approval: 13/05/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Gestational malaria in Kisangani: Efficacy of Mefloquine versus Sulfadoxine-Pyrimethamine in Intermittent Preventive Treatment
Official scientific title Mefloquine, the best alternative to replace Sulfadoxine-Pyrimethamine in Intermittent Preventive Treatment : a randomized controlled clinical trial
Brief summary describing the background and objectives of the trial Malaria is a major public health problem. Children under 5 years and pregnant women continue to pay the highest price for this disease. In order to contribute to the reduction of morbidity and mortality related to malaria during pregnancy, WHO recommends: - the long-lasting insecticide-treated net - Intermittent Preventive Treatment - very early and effective treatment. Sulfadoxine-Pyrimethamine has been used for a long time as the drug of choice for malaria prophylaxis. However, the prevalence of malaria among pregnant women remains high in Africa in general and in the DRC in particular. The efficacy of Sulfadoxine-Pyrimethamine used as Intermittent Preventive Treatment among pregnant women is being questioned by many researchers and some of them are reporting cases of resistances to Sulfadoxine-Pyrimethamine. As a result, alternative drugs are being evaluated to replace Sulfadoxine-Pyrimethamine in intermittent preventive treatment for pregnant women. Some authors believe that Mefloquine is the best alternative because it has a long half-life, with a good pharmacokinetic profile for pregnant women, and there is a low frequency of resistance to Mefloquine in Africa. In order to seek an alternative to Sulfadoxine-Pyrimethamine for intermittent preventive treatment in area dominated by equatorial facies as those of Kisangani, we considered it appropriate to conduct this study. This study aims: - to evaluate Mefloquine tolerance among pregnant women in Kisangani ; - to compare the efficacy of Mefloquine versus Sulfadoxine-Pyrimethamine among pregnant women in Kisangani.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Prevention
Anticipated trial start date 01/05/2019
Actual trial start date 15/05/2019
Anticipated date of last follow up 31/10/2019
Actual Last follow-up date 15/11/2019
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Mefloquine Mefloquine 250 mg three times a day with meal 1 day Each participant will receive 2 doses of Mefloquine during pregnancy, the first dose during inclusion and the second between 28th and 32nd week of amenorrhea 150
Control Group Sulfadoxine Pyrimethamine Each participant will receive 3 tablets in single dose (each tablet contains 500 mg of Sulfadoxine and 25 mg of Pyrimethamine) 1 day Each participant will receive 4 doses during pregnancy, in minimum intervalle of 4 weeks, from the inclusion to delivery 150 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women who will : - begin antenatal visits in medical facilities selected from gestational age between 16 and 18 weeks of amenorrhea, - have not yet received SP prophylaxis during ongoing pregnancy - sign their consent form. Pregnant women with : - positive HIV serology, - story of morbid neurological and psychiatric, - story of SP allergy - of antimalarial drug(s) use within 15 days prior to selection will be excluded. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 45 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 04/09/2018 Ethics committee of University of Kisangani
Ethics Committee Address
Street address City Postal code Country
500, Avenue Abbe Munyororo Kisangani 2012 Democratic Republic of the Congo
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome - Mefloquine will be well tolerated by Kisangani pregnant women; - Mefloquine will be more effective than SP in pregnant women in Kisangani. During pregnancy and at delivery
Secondary Outcome - Mefloquine Side-effects will be less frequent and minors, easy to control; - The prevalence of maternal anemia at delivery will be lower among pregnant women who have taken the Mefloquine compared to those who will use Sulfadoxine-Pyrimethamine; - Placental malaria parasitemia will be lower among pregnant women who have taken the Mefloquine compared to those who will use Sulfadoxine-Pyrimethamine; - The prevalence of low birth will be lower among pregnant women who have taken the Mefloquine compared to those who will use Sulfadoxine-Pyrimethamine. During pregnancy and at delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Hopital General de Reference de Kabondo Quartier artisanal Kisangani Democratic Republic of the Congo
Hopital General de Reference de Makiso Kisangani 245/15, Avenue Abbe Munyororo Kisangani Democratic Republic of the Congo
Centre de Sante de Reference Foyer 10eme avenue, Kabondo Kisangani Democratic Republic of the Congo
Centre de Sante de Reference Matete 4, quartier Lindi, Mangobo Kisangani Democratic Republic of the Congo
Centre de Sante de Reference Saint Joseph 49, 11eme avenue, Tshopo Kisangani Democratic Republic of the Congo
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Kisangani 500, Avenue Abbe Munyororo Kisangani Democratic Republic of the Congo
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Kisangani 500, Avenue Abbe Munyororo Kisangani Democratic Republic of the Congo University
COLLABORATORS
Name Street address City Postal code Country
University of Kisangani 500, Avenue Abbe Munyororo Kisangani Democratic Republic of the Congo
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Otuli Noel Labama nlabama@gmail.com +243813229686 500, Avenue Abbe Munyororo
City Postal code Country Position/Affiliation
Kisangani Democratic Republic of the Congo Searcher
Role Name Email Phone Street address
Public Enquiries Nguma Jean Didier Bosenge jdidier.bosenge@unikis.ac.cd +243855206497 500, Avenue Abbe Munyororo
City Postal code Country Position/Affiliation
Kisangani Democratic Republic of the Congo Searcher
Role Name Email Phone Street address
Scientific Enquiries Okenge Jean Pascal Manga profpascalmanga@yahoo.fr +243813288109 500, Avenue Abbe Munyororo
City Postal code Country Position/Affiliation
Kisangani Democratic Republic of the Congo Director of study
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Our IPD will be shared as a full paper in a peer review. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan 1 year Open access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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