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NCT Number: NCT01365598

Evaluation of the Gametocytocidal Efficacy and Safety of Primaquine in Uncomplicated Falciparum Malaria in Uganda

The purpose of this study is to evaluate the safety and efficacy of lower doses of primaquine compared to the dose recommended by the WHO for reducing P. falciparum gametocytes in the infected human host to prevent transmission of falciparum malaria to the anopheles mosquito vector.

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Key information

Conditions

Falciparum Malaria Infections Malaria Malaria, Falciparum Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Walukuba Health Centre IV

Jinja, Eastern Region, Uganda

About this study

A single dose of 0.75mg/kg primaquine base is recommended by the WHO to block transmission of falciparum malaria from infected humans to mosquitoes by clearing gametocytes. However, the optimal dose for safety and efficacy has not been evaluated. Dose-finding data is important because primaquine has a dose-dependent risk of causing haemolysis (destruction of blood cells) in pre-disposed individuals, such as those with G6PD deficiency. G6PD deficiency is most prevalent in malaria-endemic areas. Therefore, it is essential that data on primaquine's safety is available in such areas.

The investigators hypothesise that lower doses of primaquine have a lower risk of adverse effects compared to the WHO-recommended dose, but retain the transmission-blocking efficacy.

The investigators propose to test this hypothesis in a four-arm clinical trial with a non-inferiority design to evaluate the efficacy and a superiority design to evaluate the safety of the WHO dose (0.75mg/kg) and lower doses of primaquine for clearance of P. falciparum gametocytes in children in Uganda. The study will include a pharmacokinetic analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >/= 1 year and </= 10 years
  • Weight over 10kg
  • Fever >38 degrees C (tympanic) or history of fever in the last 24 hours
  • P. falciparum parasitaemia <500 000/µl
  • Normal G6PD enzyme function

Exclusion criteria

  • Enrolled in another study
  • Evidence of severe illness/ danger signs
  • Known allergy to study medications
  • Haemoglobin < 8g/dL)
  • Started menstruation
  • Pregnancy or breastfeeding
  • Primaquine taken within the last 4 weeks
  • Blood transfusion within the last 90 days
  • Non-falciparum malaria co-infection

Treatment and study plan

Primaquine

Drug

Single dose of oral primaquine phosphate. Comparator dose is 0.75mg/kg primaquine base. Each experimental arm is a different (reduced) dose of primaquine phosphate. Placebo contains no primaquine phosphate (non-active ingredients only).

Other names: primaquine phosphate

Primary outcomes

  1. Mean number of days to gametocyte clearance (gametocyte clearance time, GCT)

    Time frame: 14 days

    Mean number of days per treatment arm for gametocytes to become undetectable using sub-microscopic molecular testing methods (real-time nucleic acid sequence-based amplification, QT-NASBA)and interpolated from measured data points.

  2. Mean (+/- SD) maximal fall in Hb (g/dL) from enrollment to day 28 of follow-up

    Time frame: 28 days

    Mean maximal greatest negative difference in Hb (measured by Hemocue®) from enrollment value per treatment arm over 28 days follow up

Secondary outcomes

  1. Mean (+/- SD) area under the curve of gametocyte density per day during 14 days of follow-up

    Time frame: 14 days

    An estimate of the area under the curve of gametocytes (measured by QT-NASBA) seen over time, averaged per day of follow up (days 0-14) and interpolated from measured data points

  2. Requirement for blood transfusion

    Time frame: 28 days

    Percentage of children receiving blood transfusion per treatment arm during days 0-28

  3. Follow-up day of Hb nadir

    Time frame: 28 days

    Mean day of follow up (day 0-28) per treatment arm of lowest Hb measurement (by Hemocue®)

  4. Incidence of serious adverse events by sign, symptom, laboratory parameter and relationship to taking study drug

    Time frame: 28 days

    Percentage (number) per treatment arm during days 0-28

  5. Incidence of gastrointestinal symptoms after taking study drug

    Time frame: 6 days

    Percentage (number) of children with gastrointestinal symptoms per treatment arm during days 2-7

Sponsors and collaborators

Lead sponsor

London School of Hygiene and Tropical Medicine

Other

Collaborators

  • Wellcome Trust

Registry information

Official study title

Evaluation of the Efficacy and Safety of Primaquine for Clearance of Gametocytes in Uncomplicated Falciparum Malaria in Uganda

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 3, 2011
Registry last updated
Jun 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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