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.: PACTR202408837266041 Date of Approval: 02/08/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of combination of chloroquine and primaquine on malaria parasite transmission to mosquitoes compared with chloroquine alone in adult malaria patients in Dilpfan Primary Hospital in Arba Minch, southern Ethiopia
Official scientific title The impact of the combination of primaquine and chloroquine on parasite transmission to mosquitoes and clearance in Plasmodium vivax cases in Ethiopia
Brief summary describing the background and objectives of the trial The antimalarial drug primaquine (PQ) is combined with chloroquine (CQ) to target the hypnozoite stage of Plasmodium vivax and prevent transmission by targeting mature gametocytes. However, limited information exists on how quickly adding PQ reduces parasite transmission to mosquitoes and clears parasites. This study aimed to assess whether the CQ-PQ combination could reduce the transmission of P. vivax to mosquitoes and improve parasite clearance rates compared to CQ alone.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) No
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Prevention
Anticipated trial start date 22/04/2022
Actual trial start date 01/02/2023
Anticipated date of last follow up 30/09/2022
Actual Last follow-up date 30/06/2023
Anticipated target sample size (number of participants) 56
Actual target sample size (number of participants) 56
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 by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Combination of chloroquine and primaquine Already established antimalarial drugs 28 days follow-up of each participant The patients in the study were treated with PQ phosphate (Remedica Ltd Batch no. 92728, expiry date 02/2025) 28
Control Group Chloroquine alone Already established antimalarial drug 28 days The study patients were treated with CQ phosphate (Medopharm Batch no. 23A057, expiry date 12/2025) and PQ phosphate (Remedica Ltd Batch no. 92728, expiry date 02/2025), following the national guideline. 28 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients aged 15 or older Those diagnosed with P. vivax mono-infection by microscopy. Those willing to provide written consent/assent and committed to attending all scheduled visits. Pregnant and breastfeeding women Individuals with illnesses other than malaria caused by P. vivax mono-infection Those who had taken antimalarial drugs within two weeks before enrollment. Adult: 19 Year-44 Year 15 Year(s) 80 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 28/04/2022 Institutional Research Ethics Review Board
Ethics Committee Address
Street address City Postal code Country
Arba Minch Arba Minch 21 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome variable of this study was the percentage of mosquitoes with oocyst infection, oocyst density, and sporozoite infection rate in the two arms. Day 0 - before treatment, Day 1- one day post treatment, Day 3 - three days post treatment
Secondary Outcome For the secondary outcome, the study aimed to assess the clearance rate of gametocyte and asexual parasites in patients who received treatment with CQ-PQ and those who received CQ alone. Day 0 - before treatment, Day 1 -one day post treatment, Day 3 - three days post treatment, Day 7 - 7 days post treatment, Day 14 - 14 days post treatment, Day 21, 28 - 21 and 28 days post treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Woze Health Center Arba Minch Arba Minch Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
The Norwegian Programme for Capacity Development in Higher Education and Research for Development Bygdoy alle 2 Oslo 1303 Norway
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Bergen Haukelandsveien 28 Bergen 7804 Norway University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mesay Melaku mesaymelaku5@gmail.com +251902952212 Arba Minch
City Postal code Country Position/Affiliation
Arba Minch 21 Ethiopia Student
Role Name Email Phone Street address
Scientific Enquiries Fekadu Massebo fekadu.massebo@amu.edu.et +251911733885 Arba Minch
City Postal code Country Position/Affiliation
Arba Minch 21 Ethiopia Supervisor
Role Name Email Phone Street address
Public Enquiries Alemu Chemeda alemu.chemeda@amu.edu.et +251910337785 Arba Minch
City Postal code Country Position/Affiliation
Arba Minch 21 Ethiopia Department Head
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data from the trial will be available after de-identification in text, tables, figures and other forms. Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately after publication All the data will be available open for public while we submit the manuscript for publication
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 21/07/2024 31/10/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 21/07/2024 Result - 21/07/2024 Result - 21/07/2024 Result - 21/07/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information