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

Malaria Transmission Clinical Trial

Official title:

THE OPTIMAL TIMING OF PRIMAQUINE TO PREVENT MALARIA TRANSMISSION AFTER ARTEMISININ-COMBINATION THERAPY

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01906788
• Other study ID #: PRIMAQUINE STUDY
• Status: Recruiting
• Phase: Phase 4
• First received: July 20, 2013
• Last updated: July 23, 2013
• Start date: May 2013
• Est. completion date: October 2013

Study information

• Verified date: July 2013
• Source: Kilimanjaro Clinical Research Institute
• Contact: Seif Shekalaghe, MD, PhD
• Phone: +255 755 470472
• Email: sshekalaghe[@]ihi.or.tz
• Is FDA regulated: No
• Health authority: Tanzania: Food & Drug Administration
• Study type: Interventional

Clinical Trial 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"

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Malaria
• Malaria Transmission

Intervention

Drug:
• Artemether Lumefantrine

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

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

Locations

Country	Name	City	State
Tanzania	Bagamoyo Research and Training Centre	Bagamoyo

Sponsors (3)

Lead Sponsor	Collaborator
Kilimanjaro Clinical Research Institute	Ifakara Health Institute, London School of Hygiene and Tropical Medicine

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of infected mosquitoes	We will determine the proportion of infected mosquitoes on day 7 after initiation of treatment and the intensity of infection (oocyst burden)by use of membrane feeding assay technique.	day 7	No
Primary	Gametocyte prevalence and density by microscopy and QT-NASBA	By microscopy and QT-NASBA techniques we will determine and compare gametocyte prevalence and density on day 14 between the Primaquine treatment 2 and 3 arms.	Day 14	No
Secondary	Haemoglobin level	We will compare the level of baseline haemoglobin on days 3, 7, 10 and 14 after the start of treatment between the two Primaquine arms	days 3, 7, 10 and 14	Yes