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.: PACTR201709002064150 Date registered: 01/03/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Therapeutic efficacy testing of drug
Official scientific title Therapeutic Efficacy of Artemether-Lumefantrine, Artesunate-Amodiaquine, and Dihydroartemisinin Piperaquine for the Treatment of Uncomplicated Plasmodium falciparum Malaria in Nigerian Children
Brief summary describing the background and objectives of the trial The combined use of two or more antimalarial drugs with different modes of action is a recommended strategy by the World Health Organization (WHO) to improve efficacy and slow down the development and spread of resistance by the malaria parasite. The use of artemisinin derivatives in combination with antimalarials possessing longer half-lives than artemisinin drugs is thought to be effective and to prevent the development of resistance by the parasite to the individual drug. Although studies of such combinations have been carried out in African children, there is a need to monitor the efficacy of artemisinin-based combination treatments (ACTs) generally in Africa, especially with the emergence of Plasmodium falciparum insensitive parasites in southeast Asia. In Nigeria, a recent study has shown AA and AL are effective and safe treatments of uncomplicated Plasmodium falciparum malaria in under-five year olds in all geographical areas of the country. However, the recent inclusion of dihydroartemisinin-piperaquine (DHP) as a relatively new ACT for use in falciparum malaria1 has made it imperative to evaluate the efficacy and safety of DHP in Nigerian children. The present study is designed not only to monitor the efficacy of AA and AL in falciparum malaria in under-five year olds but also to evaluate the efficacy and safety of DHP and to compare the efficacy of DHP with AA and AL. The primary objective is to determine the therapeutic efficacy of AL, AA and DHP in the treatment of uncomplicated Plasmodium falciparum malaria in Nigerian children aged 6¿59 months. Secondary objectives include the following: ¿ To determine fever and parasite clearance times. ¿ To evaluate gametocyte carriage before and after treatment
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 01/07/2014
Actual trial start date 01/07/2014
Anticipated date of last follow up 31/12/2015
Actual Last follow-up date 31/12/2015
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 992
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 randomisation using a radomisation 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-lumefantrine 5 - 14 kg (20/120mg of artemether/lumefantrine) and 15 - 24 kg (40/240mg of artemether/lumefantrine) twice daily 3 days 324
Experimental Group Artesunate-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 321
Experimental Group Dihydroartemisinin-piperaquine 4.5kg - <10kg (30/240mg of dihydroartemisinin/piperaquine), 10kg - <16kg (60/480mg of dihydroartemisinin/piperaquine) and 16kg - 24kg (80/640mg of dihydroartemisinin-piperaquine) daily 3 days 347
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients were included in the study if they satisfied the following criteria: Age 6 - 59 months, History of fever / presence of fever (temp >/= 37.5oC), Mono Plasmodium falciparum infection with parasitemia of 2,000 - 200,000 asexual forms per mL and Written informed consent, including readiness to comply with follow up visits by the child's parent or guardian. Patients were excluded from the study if they had any of the following: Signs of severe malaria or other danger signs, such as: 1. Hyperparasitaemia >200,000 2. Altered consciousness 3. Inability to sit or stand unsupported 4. Severe anaemia (Hb </= 5 g/dL) 5. Convulsions 6. Shock (systolic BP < 50 mmHg, and or presence of cold clammy extremities, fast thready pulses) 7. Inability to drink or breastfeed 8. Vomiting everything, 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 25/10/2014 National Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
11th Floor, Federal Secretariat Complex Phase III, Ahmadu Bello Way Abuja 234-09 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 Day 21 Day 28 Day 35 Day 42
Primary Outcome Adequate clinical and parasitological response Day 28 Day 35 Day 42
Secondary Outcome Parasites and fever clearance times Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Day 14 Day 21 Day 28 Day 35 Day 42
Secondary Outcome Gametocyte carriage Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Day 14 Day 21 Day 28 Day 35 Day 42
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Community Health and PHC Clinic Neni, Anambra State Nigeria
General Hospital Ogwa Nigeria
General Hospital Otuasegha Ogbia LGA Nigeria
Cottage Hospital Ajikobi Ilorin Nigeria
Kura Kura
General Hospital Bodinga Nigeria
General Hospital Numan Adamawa Nigeria
Malaria Rsearch Clinic, IMRAT University of Ibadan Ibadan Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
World Bank Malaria Booster Project funding agency Nigeria
Global Fund funding agency Nigeria
Malaria Consortium funding agency Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Malaria Elimination Programme The 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 Ede 234 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Akin Sowunmi akinsowunmi@hotmail.com 08023383684 Department of Pharmacology and Therapeutics, University of Ibadan
City Postal code Country Position/Affiliation
Ibadan 234 Nigeria Professor
Role Name Email Phone Street address
Public Enquiries Godwin Ntadom ntadomg@yahoo.com 07085100800 National Malaria Elimination Programme
City Postal code Country Position/Affiliation
The Federal Ministry of Health, Abuja 234 Nigeria Asst. Coordinator
Role Name Email Phone Street address
Scientific Enquiries Stephen Oguche soguche2001@yahoo.com 08036284906 Department of Paediatrics, University of Jos
City Postal code Country Position/Affiliation
Jos 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 Disease(s) 19/09/2017 edit null Malaria ,
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 26/02/2019 edit Drug therapeutic efficacy testing Therapeutic efficacy testing of drug
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 31 Dec 2015