MalariaPhase 1/2ACTIVENCT01603251
Trial of Artemether-Lumefantrine Alone and in Combination With Ivermectin to Reduce Post-Treatment Malaria Transmission
A Phase 1/2 study testing Artemether-lumefantrine combination, Artemether-lumefantrine combination + single dose Ivermectin and Artemether-lumefantrine combination + repeated dose Ivermectin in people with Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in Burkina Faso.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Artemether-lumefantrine combination, Artemether-lumefantrine combination + single dose Ivermectin and Artemether-lumefantrine combination + repeated dose Ivermectin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBurkina Faso
- Study dates
- Jan 2013to Apr 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- asymptomatically infected individuals with any P. falciparum parasite density
Who cannot join
- 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
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- 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).
Trial locations and contacts
1 site in 1 country.
Burkina Faso1 site
Centre National de Recherche et de Formation sur le Paludisme
Ouagadougou
About this study
Official title: 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.
- Conditions
- Malaria
- Being tested
- Artemether-lumefantrine combination, Artemether-lumefantrine combination + single dose Ivermectin, Artemether-lumefantrine combination + repeated dose Ivermectin
- Keywords
- transmission, anopheles
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemether-lumefantrine combinationDrug
Artemether-Lumefantrine (AL)combination; a placebo is given together with the first and fifth dose of AL
Artemether-lumefantrine combination + single dose IvermectinDrug
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 IvermectinDrug
Artemether-lumefantrine (AL) combination + Ivermectin (200ug/kg) given together with the first and fifth dose of AL.
| Study group | Role | What they receive |
|---|---|---|
| Artemether-Lumefantrine | Active comparator | Not described Receives: Drug: Artemether-lumefantrine combination |
| Artemether-Lumefantrine + single dose Ivermectin | Experimental | Not described Receives: Drug: Artemether-lumefantrine combination + single dose Ivermectin |
| Artemether-Lumefantrine + repeated dose Ivermectin | Experimental | Not described Receives: Drug: Artemether-lumefantrine combination + repeated dose Ivermectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
The number of adverse events; number of participants with abnormal haemoglobin, biochemistry or full blood count values
Measured: 8 days
Secondary outcomes (1)
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
Measured: feeding experiments performed up to 8 days after enrolment; survival of mosquitoes determined up to day 10 after feeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2012 (estimated)
- Study startJan 2013
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center, Centre national de recherche et de formation sur le paludisme
- Responsible party
- Sponsor
- Investigators
- Teun Bousema, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603251
- Sponsor's protocol ID
- ACTIVE
- Acronym
- ACTIVE
- Status last verified
- Apr 2013
- First submitted
- 16 May 2012
- Last updated
- 18 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Randomized Controlled Trial of Artemether-Lumefantrine Alone and in Combination With Ivermectin to Reduce Post-Treatment Malaria Transmission
- ClinicalTrials.gov ID
- NCT01603251
- Acronym / sponsor ID
- ACTIVE / ACTIVE
- Conditions
- Malaria
- Keywords
- transmission, anopheles
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Radboud University Medical Center, Centre national de recherche et de formation sur le paludisme
- Study start
- Jan 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 22 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Artemether-Lumefantrine | Active comparator | Drug: Artemether-lumefantrine combination |
| Artemether-Lumefantrine + single dose Ivermectin | Experimental | Drug: Artemether-lumefantrine combination + single dose Ivermectin |
| Artemether-Lumefantrine + repeated dose Ivermectin | Experimental | Drug: Artemether-lumefantrine combination + repeated dose Ivermectin |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- asymptomatically infected individuals with any P. falciparum parasite density
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artemether-lumefantrine combinationArtemether-Lumefantrine (AL)combination; a placebo is given together with the first and fifth dose of AL | Drug | Artemether-Lumefantrine |
| Artemether-lumefantrine combination + single dose IvermectinArtemether-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 + single dose Ivermectin |
| Artemether-lumefantrine combination + repeated dose IvermectinArtemether-lumefantrine (AL) combination + Ivermectin (200ug/kg) given together with the first and fifth dose of AL. | Drug | Artemether-Lumefantrine + repeated dose Ivermectin |
Primary outcome
Safety
Time frame: 8 days
The number of adverse events; number of participants with abnormal haemoglobin, biochemistry or full blood count values
1 secondary outcome
Mosquitocidal activity
Time frame: feeding experiments performed up to 8 days after enrolment; survival of mosquitoes determined up to day 10 after feeding
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teun Bousema principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Artemether-lumefantrine combination, Artemether-lumefantrine combination + single dose Ivermectin and Artemether-lumefantrine combination + repeated dose Ivermectin in people with Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in Burkina Faso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2013.