Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000524493
Ethics application status
Approved
Date submitted
15/02/2025
Date registered
26/05/2025
Date last updated
26/05/2025
Date data sharing statement initially provided
26/05/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Shortening the Treatment Duration for Vivax Malaria: A Study Comparing 7-day and 14-day Primaquine Therapy
Scientific title
A Quasi-Experimental Trial Comparing 7-day and 14-day Primaquine Radical Therapy for Patients with Vivax Malaria
Secondary ID [1] 313882 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 336685 0
Condition category
Condition code
Infection 333187 333187 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will receive a 7-day regimen of primaquine at a dose of 1 mg/kg/day, administered orally. Drug adherence will be ensured through direct observation of therapy (DOT) during hospitalization and drug tablet count post-discharge. Allocation to treatment was non-randomized and determined by alternate allocation based on enrolment order.
Intervention code [1] 330555 0
Treatment: Drugs
Comparator / control treatment
Participants in the control group will receive the conventional 14-day regimen of primaquine at a dose of 0.5 mg/kg/day, administered orally, as per standard treatment guidelines for P. vivax malaria.
Control group
Dose comparison

Outcomes
Primary outcome [1] 340752 0
Treatment success, assessed as a composite primary outcome, is defined as the absence of both clinical relapse (no recurrence of febrile illness) and parasitological relapse (no detection of P. vivax gametocytes on blood film during follow-up). Disease relapse (recurrence of febrile illness and detection of P. vivax gametocytes in blood film).
Timepoint [1] 340752 0
Days 14, 28, 60, and 90 post-initial dose (follow-up visits).
Secondary outcome [1] 444993 0
Incidence of adverse effects: Particularly gastrointestinal (GI) symptoms, comparing both treatment groups.
Timepoint [1] 444993 0
Days 14, 28, 60, and 90 post-initial dose.

Eligibility
Key inclusion criteria
Patients of age 18 years and above, including both genders diagnosed with P. vivax malaria confirmed by peripheral smear examination/malaria fluorescent test, were included in the study.
Minimum age
18 Years
Maximum age
76 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The study excluded pregnant or lactating mothers, patients with G6PD deficiency, bleeding diathesis or haemolytic anaemias, severe complicated malaria, hypersensitivity to drugs, those using drugs that could interact with primaquine, and those who had recently received a blood transfusion (in the previous 90 days).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/03/2024
Date of last participant enrolment
Anticipated
Actual
30/08/2024
Date of last data collection
Anticipated
Actual
10/12/2024
Sample size
Target
100
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 26891 0
Pakistan
State/province [1] 26891 0
Khyber Pakhtunkhwa

Funding & Sponsors
Funding source category [1] 318352 0
Hospital
Name [1] 318352 0
Hayatabad Medical Complex
Country [1] 318352 0
Pakistan
Primary sponsor type
Hospital
Name
Hayatabad Medical Complex, Peshawar
Address
Country
Pakistan
Secondary sponsor category [1] 320753 0
None
Name [1] 320753 0
Address [1] 320753 0
Country [1] 320753 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316983 0
Hospital Research and Ethical Committee
Ethics committee address [1] 316983 0
Ethics committee country [1] 316983 0
Pakistan
Date submitted for ethics approval [1] 316983 0
13/02/2024
Approval date [1] 316983 0
23/02/2024
Ethics approval number [1] 316983 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139650 0
Dr Khalid Shahab
Address 139650 0
Department of Medicine, Hayatabad Medical Complex, Phase 4, Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan.
Country 139650 0
Pakistan
Phone 139650 0
+923139752400
Fax 139650 0
Email 139650 0
[email protected]
Contact person for public queries
Name 139651 0
Abdul Salam
Address 139651 0
Department of Medicine, Hayatabad Medical Complex, Phase 4, Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan
Country 139651 0
Pakistan
Phone 139651 0
+923139752400
Fax 139651 0
Email 139651 0
[email protected]
Contact person for scientific queries
Name 139652 0
Abdul Salam
Address 139652 0
Department of Medicine, Hayatabad Medical Complex, Phase 4, Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan.
Country 139652 0
Pakistan
Phone 139652 0
+923139752400
Fax 139652 0
Email 139652 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: No, individual participant data (IPD) for this trial will not be available due to several important reasons. Protecting participants' privacy and confidentiality is a priority, and even with de-identification, there remains a risk of re-identification. Ethical and regulatory restrictions also prevent data sharing beyond the research team, as per institutional guidelines.



What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.