We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01603251
First Posted: May 22, 2012
Last Update Posted: April 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
May 16, 2012
May 22, 2012
April 18, 2013
January 2013
April 2013   (Final data collection date for primary outcome measure)
Safety [ Time Frame: 8 days ]
The number of adverse events; number of participants with abnormal haemoglobin, biochemistry or full blood count values
Safety [ Time Frame: 8 days ]
The number of advserse events; number of participants with abnormal haemoglobin, biochemistry or full blood count values
Complete list of historical versions of study NCT01603251 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Trial of Artemether-Lumefantrine Alone and in Combination With Ivermectin to Reduce Post-Treatment Malaria Transmission
A Double Blind Randomized Controlled 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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Malaria
  • Drug: Artemether-lumefantrine combination
    Artemether-Lumefantrine (AL)combination; a placebo is given together with the first and fifth dose of AL
  • 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.
  • Drug: Artemether-lumefantrine combination + repeated dose Ivermectin
    Artemether-lumefantrine (AL) combination + Ivermectin (200ug/kg) given together with the first and fifth dose of AL.
  • Active Comparator: Artemether-Lumefantrine
    Intervention: Drug: Artemether-lumefantrine combination
  • Experimental: Artemether-Lumefantrine + single dose Ivermectin
    Intervention: Drug: Artemether-lumefantrine combination + single dose Ivermectin
  • Experimental: Artemether-Lumefantrine + repeated dose Ivermectin
    Intervention: Drug: Artemether-lumefantrine combination + repeated dose Ivermectin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
April 2013
April 2013   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
15 Years to 25 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Burkina Faso
 
 
NCT01603251
ACTIVE
Yes
Not Provided
Not Provided
London School of Hygiene and Tropical Medicine
London School of Hygiene and Tropical Medicine
  • Radboud University
  • Centre National de Recherche et de Formation sur le Paludisme, Burkina Faso
Principal Investigator: Teun Bousema LSHTM
London School of Hygiene and Tropical Medicine
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP