Ivermectin-artemisinin Combination Therapy for Eradication of Malaria

NCT05605925 | Unknown Phase 4 DMC

• 1 other identifier: MAKSHSREC-2021-237
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

Malaria remains a leading cause of morbidity and mortality globally. Uganda has the 3rd highest global burden of malaria cases (5%) and the 7th highest level of deaths (3%), accounting for over 10,500 deaths annually. Uganda also has the highest proportion of malaria cases in East and Southern Africa (23.7%). Even with the current prevention strategies including use of impregnated mosquito nets, in 2017, malaria still accounted for 27-34 % of outpatient visits, 19-30 % of hospital admissions, up to 20% of all hospital deaths nationally. A significant percentage of deaths occur at home and are not reported by the facility-based Health Management Information System (HMIS). 27.2% of inpatient deaths among children under five years of age are due to malaria. The transmission of Plasmodium from humans to mosquitoes depends on the presence of mature gametocytes transmission stages. The current first-line treatment for uncomplicated falciparum malaria is artemether lumefantrine, an artemisinin combination therapy (ACT) which rapidly clears asexual parasites and developing gametocytes but leaves mature P. falciparum gametocytes largely unaffected, thus a proportion of patients may transmit malaria after successful ACT treatment and there is an urgent need to prevent this malaria transmission.

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

• Malaria transmission rates in a household

  Malaria transmission rates in a household from an index participant. Index participant is participant who is first diagonised with malaria in that household. The transmission will be assessed using nanopore sequencing to assess for similarity between the malaria falciparum agent of the index participant and that of an household member

  Malaria Transmissibility from index participant to other household members within 28 days

Secondary Outcomes (1)

• Safety of ivermectin-artemether/lumefantrine in malaria infected patients

  daily for 30 days while following up participant

Study Arms (2)

Control arm

ACTIVE COMPARATOR

4 tabs artemether/lumefantrine 20/120mg, twice daily for 3 days

Drug: Artemether/lumefantrine

Intervention arm

EXPERIMENTAL

IVN 600 mcg/kg/day for 3 days + 4 tabs artemether/lumefantrine 20/120mg, twice daily for 3 days

Drug: Artemether/lumefantrine; Drug: Ivermectin

Interventions

Artemether/lumefantrine DRUG

4 tabs artemether/lumefantrine 20/120mg, twice daily for 3 days

Control arm; Intervention arm

Ivermectin DRUG

IVN 600 mcg/kg/day for 3 days

Intervention arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with a laboratory malaria diagnosis who consent to participate in the study will be included.
• Willingness to comply with all study procedures.
• Adults patients aged 18-65 years.

You may not qualify if:

• Participants with known hypersensitivity to Ivermectin
• Patients with a history of asthma
• Participants who live in a household of three or fewer people
• Participants who reside more than 30km from the health care facility and have other members with suspected or confirmed malaria disease in their household at the time of enrolment.
• Co-treatment with either strong cytochrome p-450 inducers including: rifampicin, carbamazepine and barbiturates or inhibitors: isoniazid, clofazimine that might potentially affect ivermectin disposition and clinical outcomes.
• Loa loa as assessed by travel history to Angola, Cameroon, Chad, Central African Republic, Congo, DR Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria and Sudan in the last 4 years.
• Active participation in another clinical trial

Sponsors & Collaborators

• Makerere University: lead

Study Sites (1)

ST. Paul's Health Center

Kasese, Uganda

RECRUITING

MeSH Terms

Conditions

Malaria

Interventions

Artemether, Lumefantrine Drug Combination; Ivermectin

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Artemether; Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Lumefantrine; Fluorenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sesquiterpenes; Terpenes; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Macrolides; Polyketides; Lactones

Central Study Contacts

Jackson Mukonzo, PhD

CONTACT

+256758113468; mukojack@yahoo.co.uk

Patrick Chelangat, Msc

CONTACT

+256704086766; chelapato25@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: November 4, 2022
• Study Start: August 4, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)