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Completed

NCT Number: NCT01603251

Trial of Artemether-Lumefantrine Alone and in Combination With Ivermectin to Reduce Post-Treatment Malaria Transmission

The purpose of this study is to determine the safety and impact of ivermectin, administered as single or repeated dose, in combination with artemether-lumefantrine in reducing the proportion of mosquitoes that survive and become infected after feeding on a blood meal from a malaria-infected individual.

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Key information

Age range

15 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Centre National de Recherche et de Formation sur le Paludisme

Ouagadougou, Burkina Faso

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • asymptomatically infected individuals with any P. falciparum parasite density

Exclusion criteria

  • age < 15 years or > 25 years
  • malaria parasite density ≥ 10,000 parasites/µL
  • clinical symptoms indicating severe malaria
  • axillary temperature ≥ 37.5°C
  • Body Mass Index (BMI) below 18 or above 32 kg/m2
  • haemoglobin concentration below 11 g/dL
  • taken ivermectin in the last three months
  • Loa loa as assessed by questionnaire, clinical examination and parasitological assessments
  • for women: pregnancy or lactation
  • known hypersensitivity to AL or IVM
  • history and/or symptoms indicating chronic illness
  • current use of tuberculosis or anti-retroviral medication
  • unable to give written informed consent
  • unwillingness to participate in two membrane feeding assays
  • travel history to Angola, Cameroon, Chad, Central African Republic, Congo, DR Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria and Sudan. If a potential participant has ever visited one or more of these countries, he or she will not be eligible for enrolment.
  • history of cardiovascular disease.
  • taking drugs that are known to influence cardiac function and to prolong QTc interval, such as class IA and III: neuroleptics, antidepressant agents, certain antibiotics including some agents of the following classes - macrolides, fluoroquinolones, imidazole, and triazole antifungal agents, certain non-sedating antihistaminics (terfenadine, astemizole) and cisapride.
  • known disturbances of electrolyte balance, e.g. hypokalaemia or hypomagnesaemia.
  • taking drugs which may be metabolized by cytochrome enzyme CYP2D6 (e.g., flecainide, metoprolol, imipramine, amitriptyline, clomipramine).

Treatment and study plan

Artemether-lumefantrine combination

Drug

Artemether-Lumefantrine (AL)combination; a placebo is given together with the first and fifth dose of AL

Artemether-lumefantrine combination + single dose Ivermectin

Drug

Artemether-lumefantrine (AL) combination + Ivermectin (200ug/kg) given once together with the first dose of AL. A placebo is given together with the fifth dose of AL.

Artemether-lumefantrine combination + repeated dose Ivermectin

Drug

Artemether-lumefantrine (AL) combination + Ivermectin (200ug/kg) given together with the first and fifth dose of AL.

Primary outcomes

  1. Safety

    Time frame: 8 days

    The number of adverse events; number of participants with abnormal haemoglobin, biochemistry or full blood count values

Secondary outcomes

  1. Mosquitocidal activity

    Time frame: feeding experiments performed up to 8 days after enrolment; survival of mosquitoes determined up to day 10 after feeding

    Daily mortality rates of (malaria-infected) Anopheles gambiae s.s. and An. funestus mosquitoes after taking a blood meal 1, 3 or 7 days after initiation of treatment

Sponsors and collaborators

Lead sponsor

London School of Hygiene and Tropical Medicine

Other

Collaborators

  • Centre national de recherche et de formation sur le paludisme
  • Radboud University Medical Center

Registry information

Official study title

A Double Blind Randomized Controlled Trial of Artemether-Lumefantrine Alone and in Combination With Ivermectin to Reduce Post-Treatment Malaria Transmission

Acronym: ACTIVE

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 22, 2012
Registry last updated
Apr 18, 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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