The Optimal Timing Of Primaquine To Prevent Malaria Transmission After Artemisinin-Combination Therapy

NCT ID: NCT01906788

Last Updated: 2013-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2013-10-31

Brief Summary

The investigators' Hypothesis is that "The correct timing of gametocytocidal drug in combination with an effective Artemisinin Combination Therapy can limit the infectiousness of malaria-infected individuals to less than one week after initiation of treatment"

Detailed Description

Global malaria elimination is back on the agenda, gametocytocidal drugs such as primaquine are currently advocated for use in the interventions that aim to interrupt malaria transmission and hence elimination. Mature gametocytes are responsible for malaria transmission. Artemisinin based combination therapies (ACTs) has limited effect on the young gametocytes. Primaquine is able to clear mature gametocytes that remain after treatment with ACTs. Complete clearance of mature gametocytes will depend on the ideal time primaquine is given after ACT. It is important therefore that is administered at optimal time in order to have significant impact on clearing gametocytes to interrupt malaria transmission. An additional consideration is operational administration of Primaquine and compliance both of which are likely to be enhanced if the drug is administered on the day of diagnosis.

In this study, the investigators aim to determine optimal timing of primaquine administration in addition to ACT by comparing administration on day 0 with administration on day 2.

The investigators' primary end points are gametocyte prevalence and density by microscopy and Quantitative Nucleic Acid Based Amplification (QT-NASBA) on day 14, which will be compared between the two primaquine treatment arms.

Conditions

Malaria Transmission

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Group 1

Active comparator: Artemether Lumefantrine 6 dose regime orally

Group Type: ACTIVE_COMPARATOR

Artemether Lumefantrine

Intervention Type: DRUG

Group 2

Experimental: Artemether Lumefantrine 6 dose regime Plus single dose Primaquine (0.75/kg) on day 0

Group Type: EXPERIMENTAL

Artemether Lumefantrine 6 dose regimen & single dose of Primaquine on day 0

Intervention Type: DRUG

Group 3

Experimental: Artemether Lumefantrine 6 dose regimen plus single dose of Primaquine (0.75/kg) on day 2

Group Type: EXPERIMENTAL

Artemether Lumefantrine 6 dose regimen and single dose Primaquine on day 2

Intervention Type: DRUG

Interventions

Artemether Lumefantrine

Intervention Type: DRUG

Artemether Lumefantrine 6 dose regimen & single dose of Primaquine on day 0

Intervention Type: DRUG

Artemether Lumefantrine 6 dose regimen and single dose Primaquine on day 2

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 3 years - 17 years
• Residents of research area
• Willingness to come for complete scheduled follow-up.
• Uncomplicated malaria with P. falciparum mono-infection
• Axillary temperature > 37.5°C and < 39.5°C, or history of fever in previous 48 hours.
• No history of adverse reactions to study medication
• Understanding of the procedures of the study by parent or guardian and willing to participate by signing written informed consent forms

Exclusion Criteria

• Haemoglobin below 9g/dl
• Inability to take drugs orally
• Known hypersensitivity to any of the drugs given
• Reported treatment with antimalarial chemotherapy in the past 2 weeks
• Evidence of chronic disease or acute infection other than malaria
• Domicile outside the study area
• Signs of severe malaria( such as respiratory distress, altered consciousness deep breathing, anaemia)
• Participating in other malaria studies conducted in the region
• Mixed malaria parasite species infection
• Positive pregnant test by Urine (UPT) if participant is female aged above 12 years
• G6PD deficient using the fluorescence spot test

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: collaborator

Ifakara Health Institute

OTHER

Sponsor Role: collaborator

Kilimanjaro Clinical Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Seif Shekalaghe, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kilimanjaro Clinical Research Institute and Ifakara Health Institute

Locations

Bagamoyo Research and Training Centre

Bagamoyo, , Tanzania

Site Status: RECRUITING

Countries

Tanzania

Central Contacts

Seif Shekalaghe, MD, PhD

Role: CONTACT

sshekalaghe@ihi.or.tz

+255 755 470472

Facility Contacts

Seif Shekalaghe, MD, PhD

Role: primary

sshekalaghe@ihi.or.tz

+255 755 470472

References

Shekalaghe S, Mosha D, Hamad A, Mbaga TA, Mihayo M, Bousema T, Drakeley C, Abdulla S. Optimal timing of primaquine to reduce Plasmodium falciparum gametocyte carriage when co-administered with artemether-lumefantrine. Malar J. 2020 Jan 21;19(1):34. doi: 10.1186/s12936-020-3121-3.

Reference Type: DERIVED

PMID: 31964380 (View on PubMed)

Other Identifiers

PRIMAQUINE STUDY

Identifier Type: -

Identifier Source: org_study_id