Primaquine's Gametocytocidal Efficacy in Malaria Asymptomatic Carriers

NCT01838902 | Completed Phase 3 DMC

• 1 other identifier: SCC 1321
• Study Type: interventional
• Target: 467
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators are interested to know if lower doses of Primaquine together with dihydroartemisinin-piperaquine can produce a similar effect of clearing both sexual and asexual parasites in asymptomatic carriers compared to the recommended dose of primaquine but with a decreased risk of haemolysis. Children (\> 1 year) and adults with normal Glucose-6-phosphate dehydrogenase enzyme levels but with asexual Plasmodium falciparum parasites on the day of screening will be invited to take part in this study.

Conditions

Malaria

Keywords

Malaria; Falciparum; Direct membrane feeding; QT-NASBA; Asexual parasite; Asymptomatic carrier; Gametocytocidal, Gametocyte; Transmission blocking; Sexual stage; Primaquine; Dihydroartemisinin; Piperaquine; Gambia; Africa

Outcome Measures

Primary Outcomes (1)

• Prevalence of P. falciparum gametocyte carriers (QT-NASBA)

  Proportion of study participants in each arm with P. falciparum gametocyte carriers as determined by quantitative nucleic acid sequence based amplification assay (QT-NASBA)

  Day 7

Secondary Outcomes (6)

• Prevalence of P.Falciparum gametocytes carriers

  Days 3, 10, 14, 28 and 42

• Proportion of individuals infectious to mosquitoes (DMFA)

  Day 7

• Haemoglobin change

  Day 0 and days 3, 7, 10, 14, 21, 28, 35 and 42

• Prevalence of infection (asexual stages)

  Day 3

• Proportion of participants with recurrent infection (PCR adjusted and unadjusted)

  Day 7 to Day 42

Study Arms (4)

Eurartesim (control)

OTHER

All participants will receive a complete course of DHA-PPQ (Eurartesim)

Drug: DHA-PPQ

Primaquine 0.75mg base/kg

EXPERIMENTAL

Participants will be randomized to receive a complete course of DHA-PPQ plus a single dose of PQ at 0.75mg/kg body weight

Drug: DHA-PPQ; Drug: PQ (0.75)

Primaquine 0.4mg base /kg

EXPERIMENTAL

Participants will be randomized to receive a complete course of DHA-PPQ plus a single dose of PQ at 0.4mg base/kg Body weight

Drug: DHA-PPQ; Drug: PQ (0.4)

Primaquine 0.2mg base/kg

EXPERIMENTAL

Participants will be randomized to receive a complete course of DHA-PPQ plus a single dose of PQ at 0.2mg base/kg body weight

Drug: DHA-PPQ; Drug: PQ (0.2)

Interventions

DHA-PPQ DRUG

Participants will receive a 3 day course of DHA-PPQ

Also known as: Eurartesim

Eurartesim (control); Primaquine 0.2mg base/kg; Primaquine 0.4mg base /kg; Primaquine 0.75mg base/kg

PQ (0.75) DRUG

Participants will receive a single dose of PQ at 0.75mg base/kg body weight

Also known as: Primaquine

Primaquine 0.75mg base/kg

PQ (0.4) DRUG

Participants will receive a single dose of PQ at 0.4mg base/kg body weight

Also known as: Primaquine

Primaquine 0.4mg base /kg

PQ (0.2) DRUG

Participants will receive a single dose of PQ at 0.2mg base/kg body weight

Also known as: Primaquine

Primaquine 0.2mg base/kg

Eligibility Criteria

• Age: 12 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥1 year
• Weight \>10 Kg
• P. falciparum mono-infection, density of at least 20 parasites/μL
• Axillary temperature \< 37.5ºC
• Resident in the study area and willingness to reside for the duration of the study
• Written informed consent (plus an assent in children \>12years of age)

You may not qualify if:

• G6PD Deficiency Haemoglobin \<8g/dl
• Known allergy to any of the study medications
• Known Pregnancy or breastfeeding
• Clear/documented history of anti-malarial treatment 2 weeks before contact with study team
• History of blood transfusion in the previous 3 months
• Any chronic or acute conditions that might interfere with the study as judged by the research clinician
• History of sickle cell anaemia

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead

Study Sites (1)

Medical Research Council Unit (MRC), The Gambia

Fajara, The Gambia

Location

Related Publications (2)

• Okebe J, Bousema T, Affara M, Di Tanna GL, Dabira E, Gaye A, Sanya-Isijola F, Badji H, Correa S, Nwakanma D, Van Geertruyden JP, Drakeley C, D'Alessandro U. The Gametocytocidal Efficacy of Different Single Doses of Primaquine with Dihydroartemisinin-piperaquine in Asymptomatic Parasite Carriers in The Gambia: A Randomized Controlled Trial. EBioMedicine. 2016 Nov;13:348-355. doi: 10.1016/j.ebiom.2016.10.032. Epub 2016 Oct 23.

  PMID: 27825738 DERIVED

• Okebe J, Bousema T, Affara M, DiTanna G, Eziefula AC, Jawara M, Nwakanma D, Amambua-Ngwa A, Van Geertruyden JP, Drakeley C, D'Alessandro U. The gametocytocidal efficacy of primaquine in malaria asymptomatic carriers treated with dihydroartemisinin-piperaquine in The Gambia (PRINOGAM): study protocol for a randomised controlled trial. Trials. 2015 Mar 1;16:70. doi: 10.1186/s13063-015-0597-1.

  PMID: 25887344 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

Primaquine

Condition Hierarchy (Ancestors)

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

• Umberto D'Alessandro, MD, PhD

  MRC Unit, Fajara The Gambia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2013
• First Posted: April 24, 2013
• Study Start: August 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: October 1, 2015
• Last Updated: March 22, 2018

Record last verified: 2018-03

Locations

TH (1)