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

Primary Purpose

Malaria

Status
Completed
Phase
Phase 1
Locations
Burkina Faso
Study Type
Interventional
Intervention
Artemether-lumefantrine combination
Artemether-lumefantrine combination + single dose Ivermectin
Artemether-lumefantrine combination + repeated dose Ivermectin
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malaria focused on measuring transmission, anopheles

Eligibility Criteria

15 Years - 25 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Centre National de Recherche et de Formation sur le Paludisme

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Artemether-Lumefantrine

Artemether-Lumefantrine + single dose Ivermectin

Artemether-Lumefantrine + repeated dose Ivermectin

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mosquitocidal activity
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

Full Information

First Posted
May 16, 2012
Last Updated
April 17, 2013
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Radboud University Medical Center, Centre national de recherche et de formation sur le paludisme
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1. Study Identification

Unique Protocol Identification Number
NCT01603251
Brief Title
Trial of Artemether-Lumefantrine Alone and in Combination With Ivermectin to Reduce Post-Treatment Malaria Transmission
Acronym
ACTIVE
Official Title
A Double Blind Randomized Controlled Trial of Artemether-Lumefantrine Alone and in Combination With Ivermectin to Reduce Post-Treatment Malaria Transmission
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Radboud University Medical Center, Centre national de recherche et de formation sur le paludisme

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
transmission, anopheles

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Artemether-Lumefantrine
Arm Type
Active Comparator
Arm Title
Artemether-Lumefantrine + single dose Ivermectin
Arm Type
Experimental
Arm Title
Artemether-Lumefantrine + repeated dose Ivermectin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Artemether-lumefantrine combination
Intervention Description
Artemether-Lumefantrine (AL)combination; a placebo is given together with the first and fifth dose of AL
Intervention Type
Drug
Intervention Name(s)
Artemether-lumefantrine combination + single dose Ivermectin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Artemether-lumefantrine combination + repeated dose Ivermectin
Intervention Description
Artemether-lumefantrine (AL) combination + Ivermectin (200ug/kg) given together with the first and fifth dose of AL.
Primary Outcome Measure Information:
Title
Safety
Description
The number of adverse events; number of participants with abnormal haemoglobin, biochemistry or full blood count values
Time Frame
8 days
Secondary Outcome Measure Information:
Title
Mosquitocidal activity
Description
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
Time Frame
feeding experiments performed up to 8 days after enrolment; survival of mosquitoes determined up to day 10 after feeding

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teun Bousema
Organizational Affiliation
LSHTM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre National de Recherche et de Formation sur le Paludisme
City
Ouagadougou
Country
Burkina Faso

12. IPD Sharing Statement

Learn more about this trial

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

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