Efficacy and Safety of High-dose Ivermectin for Reducing Malaria Transmission: A Dose Finding Study (IVERMAL)
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ClinicalTrials.gov Identifier: NCT02511353 |
Recruitment Status :
Completed
First Posted : July 30, 2015
Last Update Posted : August 23, 2018
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Condition or disease | Intervention/treatment | Phase |
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Malaria | Drug: ivermectin Drug: placebo Drug: dihydroartemisinin-piperaquine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 141 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Efficacy and Safety of High-dose Ivermectin for Reducing Malaria Transmission: A Dose Finding Study (IVERMAL) |
Actual Study Start Date : | July 2015 |
Actual Primary Completion Date : | July 2016 |
Actual Study Completion Date : | July 2016 |

Arm | Intervention/treatment |
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Placebo Comparator: placebo
Standard 3-day course of dihydroartemisinin-piperaquine, plus once a day for 3 days: placebo 600 mcg/kg/day.
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Drug: placebo
Placebo for ivermectin. Drug: dihydroartemisinin-piperaquine |
Experimental: ivermectin 300 mcg/kg
Standard 3-day course of dihydroartemisinin-piperaquine, plus once a day for 3 days: ivermectin 300 mcg/kg/day and placebo 300 mcg/kg/day.
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Drug: ivermectin Drug: placebo Placebo for ivermectin. Drug: dihydroartemisinin-piperaquine |
Experimental: ivermectin 600 mcg/kg
Standard 3-day course of dihydroartemisinin-piperaquine, plus once a day for 3 days: ivermectin 600 mcg/kg/day.
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Drug: ivermectin Drug: dihydroartemisinin-piperaquine |
- Mosquito survival [ Time Frame: Survival of mosquitoes at 14 days after feeding on blood taking from study participants who started the 3-day ivermectin and DP regimen 7 days earlier. ]
- Mosquito survival [ Time Frame: Survival of mosquitoes at each day up to day 21 or 28 after each feeding experiments performed at 0, 2 day+4h, 10, 14, 21, 28 days after start of treatment. ]
- Number of patients with malaria clinical and parasitological treatment response [ Time Frame: Up to day 28. ]
- Area under the plasma concentration versus time curve (AUC) of ivermectin [ Time Frame: Up to day 28. ]
- Area under the plasma concentration versus time curve (AUC) of piperaquine [ Time Frame: Up to day 28. ]Dihydroartemisinin-piperaquine is a combination drug. As dihydroartemisinin has a very short elimination time, only the AUC for the longer acting piperaquine component will be determined.
- Peak plasma Concentration (Cmax) of ivermectin [ Time Frame: Up to day 28. ]
- Peak plasma Concentration (Cmax) of piperaquine [ Time Frame: Up to day 28. ]Dihydroartemisinin-piperaquine is a combination drug. As dihydroartemisinin has a very short elimination time, only the Cmax for the longer acting piperaquine component will be determined.
- Tolerability as assessed by adverse events reported in a general toxicity questionnaire [ Time Frame: Up to day 28. ]
- CNS adverse events [ Time Frame: Up to day 28. ]
- Serious adverse events [ Time Frame: Up to day 28. ]
- Haemoglobin concentrations [ Time Frame: Up to day 28. ]
- QTc interval [ Time Frame: At 52 hours. ]
- Mydriasis quantitated by pupillometry [ Time Frame: Up to day 28. ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Symptomatic, uncomplicated Plasmodium falciparum infection
- Positive malaria microscopy or malaria RDT (pLDH)
- Age: 18-50 years
- Provide written informed consent
- Agree to be able to travel to clinic on days: 1, 2, 7, 10, 14, 21, and 28
Exclusion Criteria:
- Signs or symptoms of severe malaria
- Unable to provide written informed consent
- For women: pregnancy or lactation
- Hypersensitivity to ivermectin or DP
- QTc >460 ms on ECG
- Body Mass Index (BMI) below 16 or above 32 kg/m2
- Haemoglobin concentration below 9 g/dL
- Taken ivermectin in the last month
- Taken dihydroartemisinin-piperaquine in the last 12 weeks
- Loa loa as assessed by travel history to Angola, Cameroon, Chad, Central African Republic, Congo, DR Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria and Sudan
- History and/or symptoms indicating chronic illness
- Current use of tuberculosis or anti-retroviral medication
- Previously enrolled in the same study

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): NCT02511353
Kenya | |
Jaramogi Oginga Odinga Teaching and Referral Hospital | |
Kisumu, Kenya, 40100 |
Principal Investigator: | Menno R. Smit, MD, MPH | Liverpool School of Tropical Medicine | |
Principal Investigator: | Feiko ter Kuile, Prof. | Liverpool School of Tropical Medicine |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Liverpool School of Tropical Medicine |
ClinicalTrials.gov Identifier: | NCT02511353 |
Other Study ID Numbers: |
14.002 2775 ( Other Identifier: Kenya Medical Research Institute ) 6720 ( Other Identifier: Centers for Disease Control and Prevention ) |
First Posted: | July 30, 2015 Key Record Dates |
Last Update Posted: | August 23, 2018 |
Last Verified: | August 2018 |
malaria plasmodium dihydroartemisinin-piperaquine ivermectin |
Malaria Protozoan Infections Parasitic Diseases Ivermectin Piperaquine |
Dihydroartemisinin Antiparasitic Agents Anti-Infective Agents Antimalarials Antiprotozoal Agents |