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.: PACTR201203000351114 Date of Approval: 30/01/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title An RCT to measure the impact of retreatment with artemisinin-based combination on malaria incidence and resistant strains selection
Official scientific title A Randomized Clinical Trial to measure the impact of retreatment with an artemisinin-based combination on malaria incidence and its potential selection of resistant strains
Brief summary describing the background and objectives of the trial This is a IIIb, randomized, open label, clinical trial aims to investigate the impact of retreatment with an Artemisinin-Based Combination on malaria incidence and its potential selection of resistant strains. Patients will be followed-up for 42 days after treatment with the first line therapy recommended by the national authority to assess the efficacy and safety
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Quinact
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 01/03/2012
Actual trial start date 16/05/2012
Anticipated date of last follow up 31/12/2013
Actual Last follow-up date 31/12/2013
Anticipated target sample size (number of participants) 310
Actual target sample size (number of participants) 310
Recruitment status 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 A randomisation list of blocks of varying size and stratified according to the number of recruitment points in each site will be used. Sealed envelopes labelled with the patients unique code and containing the treatment allocated to the patient will be used. The envelopes will be opened only after recruitment. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Artemether-Lumefantrine Tablets 20 mg of Artemether and 120 mg of Lumefantrine Age 5 to < 15 kg: 1 tablet per dose. 15 to < 25 kg: 2 tablets per dose. 25 to < 35 kg: 3 tablets per dose. 3 days Artemether-Lumefantrine Tablets of brandname Coartem® will be used. 124
Experimental Group Artesunate-amodiaquine tablets 25mg/67,5 mg of Artesunate/Amodiaquine age 2 to 11 months (= 4,5 to < 9kg):1 tablet (25 mg/675mg) and 1-5 years (= 9 kg to < 18 kg) 1 tablet (25mg/67,5mg). 3 days Co-arsucam® 124
Experimental Group Quinine + Clindamycin Quinine: patients weighing 9 to < 11 kg: ½ tablets; 12 to < 19 kg: 1 tablets per dose; 20 to < 27 kg: 1½ tablets per dose; 28 to < 35 kg: 2 tablets per dose. 5 days Quinimax® tablet 125mg in combination with Dalacin® syrup 75mg/5ml 62
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
In order to be eligible, patients should satisfy the following inclusion criteria: 1. Males and Females aged between 12 months and 59 months inclusive. 2. Body weight of 9 Kg and above. 3. Microscopically confirmed, mono-infection of Plasmodium falciparum (parasitaemia 2,000/microliter to 200,000/microliter). 4. Fever (tympanic temperature at ¿ 38.0°C) or history of fever in the previous 24 hours. 5. Haemoglobin value ¿ 6.0 g/dl; 6. Signed informed consents by the parents or guardians. 7. Parents¿ or guardians¿ willingness and ability to comply with the study protocol for the duration of the study. Patients with at least one of the following criteria will be excluded: 1. Participation in any other investigational drug study (antimalarial or others) during the previous 30 days. 2. Known hypersensitivity and previous Serious Adverse Events related to the study drugs. 3. Severe malaria( WHO 2000) or danger signs: not able to drink or breast-feed, vomiting (> twice in 24hours), recent history of convulsions (>1 in 24h), unconscious state, unable to sit or stand. 4. Presence of intercurrent illness or any condition (cardiac, renal, hematologic, hepatic diseases) which would place the subject at undue risk or interfere with the results of the study, including known G6PD deficiency. 5. Patients who are taking drug which may prolong the QT (imidazole and triazole, antifungal agent). 6. Severe malnutrition (defined as weight for height <70% of the median NCHS/WHO reference). 7. Ongoing prophylaxis with drugs having antimalarial activity such as cotrimoxazole for the prevention of Pneumocisti carini pneumonia in children born to HIV+ women 12 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 29/09/2011 Universitary Hospital Antwerp (UZA) Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Wilrijkstraat 10 Antwerp (Edegem) 2650 Belgium
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 16/02/2012 Comité Ethique, Ecole de Santé Publique, Université de Kinshasa
Ethics Committee Address
Street address City Postal code Country
Faculté de Médecine Kinshasa 11850 Democratic Republic of the Congo
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 21/03/2012 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera road, Ntinda Kampala 6884 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome PCR adjusted efficacy: the proportion of children with PCR adequate clinical and parasitological response at day 28 (ACPR28A): all early failures before day 7 plus the recurrent parasitaemias detected later and classified by genotyping as recrudescence. - Day 28
Secondary Outcome PCR unadjusted efficacy: the proportion of children without (PCR not adjusted) treatment failure (TF28U): all treatment failures detected during the active follow up, regardless of genotyping - Day 28
Secondary Outcome Clinical efficacy: all clinical treatment failures detected during the 42 days follow up for the first line treatment, with and without PCR adjustment. As no active monitoring of parasitaemia after day 3 is planned this includes Early Treatment Failure and Late Clinical Failure following WHO criteria - Day 42
Secondary Outcome Fever clearance time (FCT): Fever clearance time is defined as the time (in days) from the time of randomization to the first two consecutive measurements on 2 different days of tympanic temperature below 38.0°C. Day 1 Day 2 Day 3
Secondary Outcome Asexual parasite clearance time (PCT): Asexual parasite clearance time is defined as the time (in days) from time of randomization to 2 consecutive negative blood slides (collected at different days). The time to the event will be taken as the time to the first negative slide. Day 0 Day 1 Day 2
Secondary Outcome Gametocytaemia (prevalence and density) Day 7 Day 14 Day 21 Day 28
Secondary Outcome Hb changes Day 0 - Day 28
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre de Santé Lisungi Route Kimwenza n°23 Commune de Mont-Ngafula Kinshasa n/a Democratic Republic of the Congo
Kazo Health centre IV Rushere Kiruhura P.O Box 5 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Research Foundation Flanders / Fond voor Wetenschappelijk Onderzoek (FWO) Edmondstraat 5 Brussels 1000 Belgium
EDCTP Laan van Nieuw Oost Indië 334 The Hague 2509 AA PoBox 93015 Netherlands
Belgium Development Agency Rue Haute 147 Brussels 1000 Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Jean-Pierre Van geertruyden Universiteitsplein 1 Antwerpen (Wilrijk) BE-2610 Belgium University
Primary Sponsor University of Antwerp Universiteitsplein 1 Antwerp (Wilrijk) 2610 Belgium University
COLLABORATORS
Name Street address City Postal code Country
Pascal Lutumba Université de Kinshasa Kinshasa B.P. 747 Kinshasa X Democratic Republic of the Congo
Tinto Halidou Institut de Recherche en Science de la Santé (IRSS-DRO) / Centre MURAZ BOBO-DIOULASSO PoBox 545 Burkina Faso
Martin Peter Grobusch Medicine Department of Infectious Diseases, Division of Internal Medicine Academic Medical Center, University of Amsterdam. Meibergdreef 9 Amsterdam PO Box 22660, 1100 Netherlands
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hypolite Mavoko Muhindo mavoko@yahoo.com +243 99 44 06 532 Université de Kinshasa, Faculté de Médecine
City Postal code Country Position/Affiliation
Kinshasa 747 Democratic Republic of the Congo Medical doctor
Role Name Email Phone Street address
Principal Investigator Carolyn Nabasumba carolyn.nabasumba@gmail.com +256 774 51 65 27
City Postal code Country Position/Affiliation
Mbarara 930 Uganda Medical doctor
Role Name Email Phone Street address
Public Enquiries Joachim Y Doua joachimy.doua@ua.ac.be +32 326 528 74 Universiteitplein
City Postal code Country Position/Affiliation
Antwerp-Wilrijk BE-2610 Belgium Research assistant
Role Name Email Phone Street address
Scientific Enquiries Jean-Pierre Van geertruyden Jean-pierre.vangeertruyden@ua.ac.be + 32 32 652 528 Universiteitsplein 1
City Postal code Country Position/Affiliation
Antwerp-Wilrijk BE-2610 Belgium Study coordinator
REPORTING
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Result URL Hyperlinks
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