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

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ClinicalTrials.gov Identifier: NCT01603251
Recruitment Status : Completed
First Posted : May 22, 2012
Last Update Posted : April 18, 2013
Sponsor:
Collaborators:
Radboud University
Centre National de Recherche et de Formation sur le Paludisme, Burkina Faso
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Malaria Drug: Artemether-lumefantrine combination Drug: Artemether-lumefantrine combination + single dose Ivermectin Drug: Artemether-lumefantrine combination + repeated dose Ivermectin Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind Randomized Controlled Trial of Artemether-Lumefantrine Alone and in Combination With Ivermectin to Reduce Post-Treatment Malaria Transmission
Study Start Date : January 2013
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Active Comparator: Artemether-Lumefantrine Drug: Artemether-lumefantrine combination
Artemether-Lumefantrine (AL)combination; a placebo is given together with the first and fifth dose of AL

Experimental: Artemether-Lumefantrine + single dose Ivermectin Drug: Artemether-lumefantrine combination + single dose Ivermectin
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.

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




Primary Outcome Measures :
  1. Safety [ Time Frame: 8 days ]
    The number of adverse events; number of participants with abnormal haemoglobin, biochemistry or full blood count values


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   15 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01603251


Locations
Burkina Faso
Centre National de Recherche et de Formation sur le Paludisme
Ouagadougou, Burkina Faso
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Radboud University
Centre National de Recherche et de Formation sur le Paludisme, Burkina Faso
Investigators
Principal Investigator: Teun Bousema LSHTM

Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT01603251     History of Changes
Other Study ID Numbers: ACTIVE
First Posted: May 22, 2012    Key Record Dates
Last Update Posted: April 18, 2013
Last Verified: April 2013

Keywords provided by London School of Hygiene and Tropical Medicine:
transmission
anopheles

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Lumefantrine
Artemether
Artemisinins
Artemether-lumefantrine combination
Ivermectin
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antifungal Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics