Efficacy and Safety of a Single Low-dose Primaquine for the Clearance of Gametocytes

NCT02090036 | Completed Phase 4 DMC

• 1 other identifier: 1.0.2014
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess efficacy and safety of a single low-dose Primaquine added to standard artemether/lumefantrine treatment for the clearance of Plasmodium falciparum gametocytes among patients with uncomplicated malaria aged 1 year and above regardless of their G6PD status.

Conditions

Plasmodium Falciparum

Keywords

Efficacy; Safety; Primaquine; Artemether-lumefantrine; Gametocytes

Outcome Measures

Primary Outcomes (1)

• Number of days per treatment arm for gametocytes to become undetectable using Quantitative nucleic acid sequence based assay (QT-NASBA).

  14 days

Secondary Outcomes (1)

• Mean maximal fall in hemoglobin (g/dl) from enrolment to day 28 of follow-up defined as mean greatest negative difference in hemoglobin per treatment arm.

  28 days.

Other Outcomes (1)

• Proportion of patients with urine color change score ≥ 5 using Hillmen Urine Colour Chart, per treatment arm.

  28 days.

Study Arms (2)

artemether-lumefantrine+placebo

ACTIVE COMPARATOR

In the artemether-lumefantrine arm, the first dose of artemether-lumefantrine will be administered concomitantly with a single-dose placebo. A volume of normal saline will be measured based on weight bands and then will be given to patients.

Drug: Placebo (For artemether-lumefantrine arm)

artemether-lumefantrine+primaquine

EXPERIMENTAL

All the recruited patients will be treated with a six doses, 3 days artemether-lumefantrine treatment regimen. However, patients randomized to the artemether-lumefantrine+primaquine arm will be given 0.25 mg/kg single-dose primaquine concomitantly with artemether-lumefantrine first dose.

Drug: Primaquine (For artemether-lumefantrine+primaquine arm)

Interventions

Primaquine (For artemether-lumefantrine+primaquine arm) DRUG

A 0.25 mg/kg single-dose primaquine will be administered concomitantly with the first dose of artemether-lumefantrine in all patients randomized into the artemether-lumefantrine+primaquine arm.

artemether-lumefantrine+primaquine

Placebo (For artemether-lumefantrine arm) DRUG

Volume of normal saline mixed with coloured fruit juice measured based on weight bands will be given orally concomitantly with first dose of artemether-lumefantrine.

artemether-lumefantrine+placebo

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 1 year and above and neither pregnant nor breast feeding.
• Weight over 10 kg.
• Body temperature ≥37.5°C) or history of fever in the last 24 hours.
• P. falciparum mono-infection.

You may not qualify if:

• Evidence of severe illness malaria or danger signs.
• Known allergy to study medications.
• Hemoglobin \<8 g/dl.
• Antimalarials taken within last 2 weeks.
• Blood transfusion within last 90 days and evidence of recent use (within 14 days)of or will be taking other drugs known to cause hemolysis in G6PD deficient subjects.

Sponsors & Collaborators

• Muhimbili University of Health and Allied Sciences: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Muhimbili University of Health and Allied Sciences

Dar es Salaam, 65001, Tanzania

Location

Related Publications (3)

• Mwaiswelo R, Ngasala B, Jovel I, Xu W, Larsson E, Malmberg M, Gil JP, Premji Z, Mmbando BP, Martensson A. Prevalence of and Risk Factors Associated with Polymerase Chain Reaction-Determined Plasmodium falciparum Positivity on Day 3 after Initiation of Artemether-Lumefantrine Treatment for Uncomplicated Malaria in Bagamoyo District, Tanzania. Am J Trop Med Hyg. 2019 May;100(5):1179-1186. doi: 10.4269/ajtmh.18-0729.

  PMID: 30860013 DERIVED

• Mwaiswelo R, Ngasala B, Jovel I, Aydin-Schmidt B, Gosling R, Premji Z, Mmbando B, Bjorkman A, Martensson A. Adding a single low-dose of primaquine (0.25 mg/kg) to artemether-lumefantrine did not compromise treatment outcome of uncomplicated Plasmodium falciparum malaria in Tanzania: a randomized, single-blinded clinical trial. Malar J. 2016 Aug 26;15(1):435. doi: 10.1186/s12936-016-1430-3.

  PMID: 27565897 DERIVED

• Mwaiswelo R, Ngasala BE, Jovel I, Gosling R, Premji Z, Poirot E, Mmbando BP, Bjorkman A, Martensson A. Safety of a single low-dose of primaquine in addition to standard artemether-lumefantrine regimen for treatment of acute uncomplicated Plasmodium falciparum malaria in Tanzania. Malar J. 2016 Jun 10;15:316. doi: 10.1186/s12936-016-1341-3.

  PMID: 27287612 DERIVED

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

Primaquine

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Andreas Martensson, PhD

  Karolinska Institutet

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: March 16, 2014
• First Posted: March 18, 2014
• Study Start: July 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 8, 2014

Record last verified: 2014-12

Locations

TA (1)