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

This study has been completed.
Sponsor:
Collaborators:
Radboud University
Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01603251
First received: May 16, 2012
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • Safety [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
    The number of adverse events; number of participants with abnormal haemoglobin, biochemistry or full blood count values


Secondary Outcome Measures:
  • Mosquitocidal activity [ Time Frame: feeding experiments performed up to 8 days after enrolment; survival of mosquitoes determined up to day 10 after feeding ] [ Designated as safety issue: No ]
    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


Enrollment: 120
Study Start Date: January 2013
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   15 Years to 25 Years
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, Ouagadougou, Burkina Faso
Investigators
Principal Investigator: Teun Bousema LSHTM
  More Information

No publications provided

Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT01603251     History of Changes
Other Study ID Numbers: ACTIVE
Study First Received: May 16, 2012
Last Updated: April 17, 2013
Health Authority: Burkina Faso: Ministry of Health
United Kingdom: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on August 01, 2014