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.: PACTR202007653561223 Date of Approval: 17/07/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Monitoring safety of single-low dose primaquine co-administered with ALu in routine healthcare practice: addressing potential implementation challenges and policy options for effective roll out
Official scientific title Monitoring safety of single-low dose primaquine co-administered with ALu in routine healthcare practice: addressing potential implementation challenges and policy options for effective roll out
Brief summary describing the background and objectives of the trial The success of malaria control programmes have contributed to a decrease in malaria mortality rates by approximately 50% worldwide over the past 15 years. To maintain this gain, WHO recommends use primaquine, in conjunction with artemisinin-based combination therapy (ACT), to block Plasmodium falciparum transmission in areas approaching malaria elimination and/or facing artemisinin resistance. East Africa including Tanzania has latter properties which may justify relevance of this recommendation. Primaquine (PQ) may cause haemolytic side effects in individual who have G6PD deficiency; the potential for haemolysis depends on the dose. The current WHO recommended dose of 0.25mg/kg is low enough to mitigate the side risk of haemolysis in G6PD deficiency individuals. This low dose also enables treatment without requiring G6PD testing. Twenty-one countries worldwide have included PQ as part of a first line treatment for P. falciparum in their national policy. Only three African countries appear in this list. Concerns related to safety monitoring of this new treatment recommendation is a key barrier that may explain failure for its consideration in malaria policy in nearly all sub Saharan countries. The project aims to determine readiness, challenges and policy options for effective roll out of recommended malaria treatment regimen in routine healthcare.
Type of trial CCT
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: Drugs
Anticipated trial start date 30/03/2020
Actual trial start date 30/03/2020
Anticipated date of last follow up 31/03/2021
Actual Last follow-up date 06/08/2020
Anticipated target sample size (number of participants) 600
Actual target sample size (number of participants) 413
Recruitment status Completed
Publication URL https://pubmed.ncbi.nlm.nih.gov/34627236/
Secondary Ids Issuing authority/Trial register
NIMRHQR.8aVol.IX3114 Tanzania National Institute for Medical Research NIMR
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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Low dose primaquine plus ACT Once, a single dose of primaquine at one point in time three days Patients receive a single dose of primaquine in the first day of Artemisinin-based Combination Therapy (ACT) dose. ACT is given for three days and therefore patients receive primaquine on the first day of treatment under direct observation 413
Control Group NA because there is no control arm in this study N/A because there is no control arm in this study N/A because there is no control arm in this study N/A because there is no control arm in this study 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria include: (i). All patients with uncomplicated P.falciparum malaria (ii). Participants with 1 year and above Exclusion criteria include: (i). Pregnant women (ii). Lactating mother with children of 6 months and below 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Infant: 1 Month-23 Month,Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 12 Month(s) 100 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 29/05/2019 National Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
3 Barack Obama Drive, 11101 Dar es Salaam Dar es Salaam 9653 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The proportion of health care who complied to the Primaquine Roll Out Monitoring Pharmacovigilance Tool PROMPT once - at the end of the study
Secondary Outcome The proportion of patients who came back at day 7 schedule for follow up once - at the end of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nyamwage dispensary Rufiji distirct Costal United Republic of Tanzania
Mkupuka dispensary Rufiji District Costal United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
European and Developing Countries Clinical Trials Partnership 2509 AA The Hague The Hague 93015 Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ifakara Health Institute P.O Box 78373 Dar es Salaam 78373 United Republic of Tanzania Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dominic Mosha dmosha@ihi.or.tz +255784477276 463 Kiko Avenue, Mikocheni A
City Postal code Country Position/Affiliation
Dar es Salaam 78373 United Republic of Tanzania Senior Research Scientist
Role Name Email Phone Street address
Public Enquiries Priscilla Mlay pmlay@ihi.or.tz +255620704425 463 KikoAvenue, Mikocheni
City Postal code Country Position/Affiliation
Dar es Salaam 78373 United Republic of Tanzania Administrator
Role Name Email Phone Street address
Scientific Enquiries Mwaka Athuman amwaka@ihi.or.tz +255764580644 463 Kiko Avenue, Mikocheni B
City Postal code Country Position/Affiliation
Dar es Salaam 78373 United Republic of Tanzania Senior Research Scientist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We shall share IPD as well as to include summary results within the trial registration record Informed Consent Form,Statistical Analysis Plan,Study Protocol To share IPD between July and December 2021 which is within 12 after study completion Will depends on the best way for sharing IPD that will be agreed between the IPD donor and IPD recipient
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 22/02/2023 09/10/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 22/02/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information