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Assessing the effect of single-dose primaquine on parasite transmission and clearance over artemether-lumefantrine alone treatment in Plasmodium falciparum patients.

Assessing the effect of single-dose primaquine on parasite transmission and clearance over artemether-lumefantrine alone treatment in Plasmodium falciparum patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202502642820967
Enrollment
146
Registered
2025-02-24
Start date
2023-03-06
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Interventions

Artemether lumefantrine
Artemether lumefantrine plus single dose primaquine

Sponsors

University of Bergen
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Aged =15 Fever (body temperature =37.5 °C) or history of fever in the last 24 hr Microscopically confirmed P. falciparum mono-infections The parasitemia ranges from 1000 to 100000 per microliter of asexual forms Willingness to abide by the study protocol Ability to swallow oral treatment Ready for follow-up visits and provided written informed consent/assent before enrolment

Exclusion criteria

Exclusion criteria: Severe malaria or danger signs Known allergy to artemether-lumefantrine or primaquine Those who take anti-malarial drugs or drugs with anti-malarial properties within 2 weeks Pregnant (self-reported) Breastfeeding women The presence of febrile conditions caused by diseases other than malaria Known serious or chronic medical conditions (e.g., cardiac, renal, hepatic diseases, sickle cell disease, HIV/AIDS)(self-reported) Taking regular medication, which may interfere with artemether-lumefantrine and primaquine

Design outcomes

Primary

MeasureTime frame
The proportion of P. falciparum cases with parasitological responses in the artemether-lumefantrine plus primaquine group compared with the artemether-lumefantrine group using microscopy. The proportion of patients with gametocytes at baseline and subsequent follow-up days using microscopy.

Secondary

MeasureTime frame
The number of P. falciparum cases with reinfection and recrudescence at the later stage of follow-up The proportion of patients with negative PCR result in the artemether-lumefantrine plus primaquine group compared with the artemether-lumefantrine group

Countries

Ethiopia

Contacts

Public ContactSamson Tizazu

Ass.Prof.Industrial and Environmental Biotechnology

samtiz161@gmail.com+251920987320

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026