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: www.pactr.org
Trial no.: PACTR201510001189370 Date registered: 03/07/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Drug therapeutic efficacy testing
Official scientific title Therapeutic efficacy of artemether-lumefantrine and artesunate-amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in Nigerian children
Brief summary describing the background and objectives of the trial The first Drug Therapeutic Efficacy Tests (DTET) on chloroquine and sulphadoxine-pyrimethamine were conducted between 1987 and 1999 in four sentinel sites situated in Calabar, Ibadan, Kaduna and Enugu. The most recent study of the two medicines conducted in six sentinel sites in 2002 showed a mean sensitivity of 39% and 57% for chloroquine and Sulphadoxine-pyrimethamine respectively as against the minimum of 75% recommended by WHO at that time. This abysmally high resistance demonstrated by the two medicines led to the search for immediate replacement. By 2001, the World Health Organization had recommended that all countries experiencing significant resistance to chloroquine and sulphadoxine-pyrimethamine should introduce artemisinin based combination medicines. Between July and September 2004, efficacy trials were carried out using Artemether-Lumefantrine and Artesunate-Amodiaquine in the six Sentinel sites across the country. The outcome of this informed the adoption, in 2005, of the two medicines as the medicine of choice and the alternate medicines respectively in the country. In the past six years, over 60 million treatment courses of ACTs have been deployed to the public sector alone. With increasing use of these commodities, there is need for closer monitoring. The primary objective is to determine the therapeutic efficacy of AL and AA in the treatment of uncomplicated Plasmodium falciparum malaria in Nigerian children aged 6¿59 months as described by the WHO protocol (2003) and using a 28-day follow-up period. Secondary objectives include the following: To determine the fever and parasite clearance times (where possible). To assess gametocyte carriage before and after treatment in the study population.
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 03/05/2009
Actual trial start date 03/05/2009
Anticipated date of last follow up 15/11/2010
Actual Last follow-up date 16/11/2010
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 747
Recruitment status Completed
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 Simple randomization using a randomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group artemether plus lumefantrine 5 ¿ 14 kg (20/120mg of artemether/lumefantrine) and 15 ¿ 24 kg (40/240mg of artemether/lumefantrine) twice daily 3 days 360
Experimental Group artesunate plus amodiaquine ¿4.5kg - <9kg (25/67.5mg of artesunate/amodiaquine), ¿9kg - <18kg (50/135mg of artesunate/amodiaquine) and ¿18kg - <24kg (100/270mg of artesunate/amodiaquine) daily 3 days 387
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children age 6¿59 months. History of fever / Measured fever (temp > 37.4). Mono P. falciparum infection with parasitemia >/=1000 to </= 200,000 parasites per microlitre of blood. Written informed consent, including readiness to comply with follow up visits by the child¿s parent or other adult guardian. Signs of severe malaria or other danger signs, such as: 1. Unconsciousness 2. Not able to sit or stand 3. Severe anaemia (Hb </= 5 g/dL) 4. Convulsions 5. Shock (systolic BP < 50 mmHg) 6. Inability to drink or breastfeed 7. Vomiting everything Other diseases associated with fever. Severe malnutrition. History of allergy to test drugs. 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 28/10/2009 National Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ministry of Health, Shehu Sagari Way, Garki Abuja 234 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Early treatment failure day 1 day 2 day 3
Primary Outcome Late clinical failure Day 3 Day 4 Day 5 Day 6 Day 7 Day 14
Primary Outcome Late parasitological failure Day 14
Primary Outcome Adequate clinical and parasotilogical response Day 14 Day 21 Day 28
Secondary Outcome Fever clearance time Day 1 Day 2 Day 3 Day 7 Day 14 Day 21 Day 28
Secondary Outcome Parasite clearance time Day 1 Day 2 Day 3 Day 7 Day 14 Day 21 Day 28
Secondary Outcome Gametocyte carriage Day 0 Day 1 Day 2 Day 3 Day 7 Day 14 Day 21 Day 28
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Makarfi General Hospital Makarfi Local Govt Makarfi, Kaduna State 234 Nigeria
Ijede Primary Health Centre Ikorodu Local Government Area Ikorodu, Lagos State 23401 Nigeria
Primary Health Centre Ikot Ansa Calabar Municipal Local Govt. area Nigeria
Malaria Research Clinic and Laboratories Institute of Medical Research and Training, College of Medicine, University of Ibadan Ibadan 234 Nigeria
General Hospital Damboa Damboa Local Government Area Damboa, Maiduguri 234 Nigeria
Agbani District Hospital Agbani Nkanu-West Local Government Area, Enugu State 234 Nigeria
Barkin Ladi General Hospital Barkin Ladi Plataeu State 234 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
National Malaria and Vector Control Federal Ministry of Health Abuja 234 Nigeria
National Malaria and Vector Control Federal Ministry of Health Abuja 234 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Malarial and Vector Control Federal Ministry of Health Abuja 234 Nigeria Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Academic Centre of Excellence for Genomics of Infectious Diseases Redeemer University, Nigeria Mowe 234 Nigeria
Academic Centre of Excellence for Genomics of Infectious Diseases Redeemer University, Nigeria Mowe 234 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tolulope Olayemi Sofola tosofola@yahoo.com 08033051149 National Malaria Control Programme, Federal Ministry of Health
City Postal code Country Position/Affiliation
Abuja 234 Nigeria National Coordinator
Role Name Email Phone Street address
Public Enquiries Bayo Fatunmbi fatunmbib@wpro.who.int +855 (0) 12468793 World Health Organization, Regional Office for the Western Pacific
City Postal code Country Position/Affiliation
Phnom Pen Cambodia Technical Officer (Monitoring & Evaluation)
Role Name Email Phone Street address
Scientific Enquiries Akin Sowunmi akinsowunmi@hotmail.com 08052157893 Dept. of Pharmacology & Therapuetics, University of Ibadan
City Postal code Country Position/Affiliation
Ibadan 234 Nigeria Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result URL Hyperlinks Baseline Characters Participant Flow Adverse Events Outcome Measures Description
Link To Protocol
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 26/02/2019 edit Not Applicable
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 26/02/2019 edit 01 Jan 0001 15 Nov 2010