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.: PACTR202102893629864 Date of Approval: 23/02/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of dual parenteral artemisinin-based combination therapy for cerebral malaria in a randomized control trial in Nigerian children.
Official scientific title Efficacy of dual parenteral artemisinin-based combination therapy for cerebral malaria in a Tripple blind randomized control trial in Nigerian children.
Brief summary describing the background and objectives of the trial Evidence exists as to the criticality of the first 24 hours in the management of severe cerebral malaria. This could serve as a potential safety net for improved outcomes with prompt treatment and utilization of effective therapy. The morbidity and mortality rate (35%) with the current parenteral monotherapy for the initial treatment of cerebral malaria is unacceptably high. Combination therapy and a shorter course of effective medication have been shown to improve outcomes in human subjects in the treatment of other diseases. This is an RCT designed to determine the efficacy of dual parenteral antimalarial therapy compared with standard of care in selected tertiary teaching hospitals in Nigeria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) DPACT
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Treatment: Drugs
Anticipated trial start date 21/07/2021
Actual trial start date
Anticipated date of last follow up 26/10/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 359
Actual target sample size (number of participants)
Recruitment status Active, not 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 Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Parenteral dual artemisinin based antimalarial artesunate and quinine 1. Intravenous quinine at a dose of 20mg/kg loading dose and subsequently 10 mg /kg 8 hourly for 72hr. However, if the patient remains unconscious the dose would be reduced to 7.5 mg/kg 8hrly until he/she regains consciousness. In parallel. 2. Intravenous artesunate at 3 mg/kg if weight is less than 20kg or 2.4mg/kg if weight is greater than 20kg at 0, 12, and 24 hours and subsequently a daily dose of 1.2 mg/kg /day until conscious. Until the patient regained consciousness There will be three arms of the study; one arm will receive parenteral quinine and artesunate; a second will receive parenteral quinine only, and the third will receive parenteral artesunate. In order to facilitate blinding, the monotherapy groups will also receive intravenous dextrose water or water for injection to maintain the similarity of treatment administered with the dual-therapy group. A clinical pharmacologist will the appropriate formulations based on the treatment allocation to the clinician who will administer the intervention. 120
Control Group Monotherapy with either quinine alone or artesunate alone Control Arm B This arm will receive intravenous artesunate at 3 mg/kg if weight is less than 20kg or 2.4mg/kg if weight is greater than 20kg at 0, 12, and 24 hours and subsequently a daily dose of 1.2 mg/kg /day until conscious. Additionally, intravenous 10% dextrose water will be given in lieu of intravenous quinine. Control Arm C Intravenous quinine at a dose of 20mg/kg loading dose and subsequently 10 mg /kg 8 hourly for 72hr. However, if the patient remains unconscious the dose would be reduced to 7.5 mg/kg 8hrly until he/she regains consciousness. Until the patient regained full consciousness This group will receive the standard of care of either intravenous artesunate( 120 participants) or intravenous quinine (120 participants) 240 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Children between the ages of 6 months to 17 years as at the last birthday 2.Children with unarousable coma lasting more than 30 minutes in the presence of demonstratable peripheral asexual P. falciparum parasitemia. 3.Children who develop deterioration in their level of consciousness after admission and demonstrate asexual Plasmodium falciparum in the peripheral blood. 1.Children with positive biochemical and/or microbiological CSF result consistent with a diagnosis of meningitis 2.Children who have intracranial infections or intracranial space-occupying lesions 3.Children with previous neurological deficit either focal or global Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 6 Month(s) 17 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 05/06/2018 BUTH Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ilorin Ogbomoso road, Ogbomoso Ogbomoso 210231 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome of this study is the effectiveness of dual parenteral antimalaria in the treatment of cerebral malaria compared to the standard of care in terms of survival and full recovery in tertiary hospitals in Nigeria. One time point- until there recovery of consciousness
Secondary Outcome The secondary outcomes include the parasite clearance rate, fever defervescence, time to recovery of consciousness, and the side effect profile of interventions (treatment and control arms). One time point- until there recovery of consciousness
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Paediatric University College Hospital Ibadan Layi Ayanniyi Street, Ibadan Ibadan 200212 Nigeria
Department of Paediatrics Bowen University Teaching Hospital Ogbomoso Ilorin Ibadan Express Road Ogbomoso 210231 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Alao Michael and co authors Layi Ayanniyi Street, Ibadan Ibadan 200212 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alao Michael and Co Authors Layi Ayanniyi Street, Ibadan Ibadan 200212 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Adebola Emmanuel Orimadegun Layi Ayanniyi Street, Ibadan Ibadan 200212 Nigeria
Ibrahim Olayinka Rasheed Department of Paediatrics, Federal Medical Centre, Kastina, Kastina State, Nigeria Kastina 820252 Nigeria
Abayomi O Oyenuga Minneapolis, MN 55455, United States Minnesota 55455 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Michael Alao mikevikefountains@gmai.com +2348053967839 Layi Ayanniyi Street, Ibadan
City Postal code Country Position/Affiliation
Ibadan 200212 Nigeria Consultant
Role Name Email Phone Street address
Scientific Enquiries Adebola Orimadegun beorimadegun@yahoo.com +2348058266882 Layi Ayanniyi Street, Ibadan
City Postal code Country Position/Affiliation
Ibadan 200212 Nigeria Consultant
Role Name Email Phone Street address
Public Enquiries Abayomi Oyenuga oaoyenuga@gmail.com +16513996981 Minneapolis, MN 55455, United States
City Postal code Country Position/Affiliation
Minnesota 55455 United States of America Clinician Biostatistician
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Patient data will be de-identified and stored encrypted in a passworded computer. The de-identified data will be publicly available for 2 years on the trial website. De-identified data will also be stored in highly secured clouding computing. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The Informed Consent Form will be redacted before sharing it publicly. Patient identifiers will be removed from all documents for public access. Open access to de-identified data set which can be used for any analysis related to cerebral malaria in the paediatric population
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://uch-ibadan.org.ng/ 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