NCT04767191

Brief Summary

WHO recommends that Therapeutic Efficacy Studies (TES) for 1st and 2nd line antimalarial medicines should be routinely carried out and data made available for decision-making due to the threat of emergence and spread of artemisinin resistance in malaria-endemic countries, especially in Africa. In line with this WHO recommendation, Kenya Ministry of Health (MOH) is conducting the TES to determine the efficacy of artemether lumefantrine (AL), and dihydroartemisinin-piperaquine (DHP), the first and second line treatment of uncomplicated malaria in Kenya. The objective of this study is to inform the decisions or actions made by a public health authority (Kenya Ministry of Health) to inform decision on revision of the antimalarial guidelines and policy in Kenya. Jhpiego's Impact Malaria project in Kenya, with funding and technical oversight from US President's Malaria Initiative (PMI) through USAID and CDC, will support the Kenya MOH in its effort to evaluate the efficacy of AL and DHP in the treatment of children with uncomplicated malaria. The study is being conducted by Kenya MOH, with technical support and funding by PMI-USAID through Jhpiego in Kenya.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

March 15, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2022

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

1.8 years

First QC Date

February 11, 2021

Last Update Submit

October 30, 2023

Conditions

Uncomplicated Malaria

Outcome Measures

Primary Outcomes (2)

  • Number of patients (in the Artemether Lumefantrine arm) with clinical and parasitological cure (i.e. free of malaria symptoms and parasites) assessed clinically and via microscopy and rapid diagnostic test.

    By day 28 post-treatment

  • Number of patients (in the Dihydroartemisinin-Piperaquine arm) with clinical and parasitological cure (i.e. free of malaria symptoms and parasites) assessed clinically and via microscopy and rapid diagnostic test.

    By day 42 post-treatment

Secondary Outcomes (4)

  • Number of patients (in the Artemether Lumefantrine arm arm) with treatment-related adverse events

    by day 28 post-treatment

  • Number of patients (in the Dihydroartemisinin-Piperaquine arm) with treatment-related adverse events

    by day 42 post-treatment

  • Number of patients (in the Artemether Lumefantrine arm) with molecular markers of drug resistance assessed via phenotype test

    by day 28 post-treatment

  • Number of patients (in the Dihydroartemisinin-Piperaquine arm) with molecular markers of drug resistance assessed via phenotype test

    by day 42 post-treatment

Study Arms (2)

artemether lumefantrine

ACTIVE COMPARATOR

The drug is approved and in use by the Kenya Ministry of Health as the 1st line treatment for malaria. The study is to assess the continued efficacy of the drug.

Drug: artemether lumefantrine

dihydroartemisinin piperaquine

ACTIVE COMPARATOR

The drug is approved and in use by the Kenya Ministry of Health as the 2nd line treatment for malaria. The study is to assess the continued efficacy of the drug.

Drug: dihydroartemisinin piperaquine

Interventions

artemether lumefantrineDRUG

The drugs are approved and in use by the Kenya Ministry of Health as the 1st and 2nd line treatment for malaria. The study is to assess the continued efficacy of the two drugs in the treatment of uncomplicated malaria.

artemether lumefantrine
dihydroartemisinin piperaquineDRUG

Antimalarial Combinations

dihydroartemisinin piperaquine

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • age between 6 months to 59 months; mono-infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection);
  • parasitaemia of 1,000 - 100,000/µl asexual forms;
  • presence of axillary temperature ≥ 37.5 °C or history of fever during the past 24 h;
  • ability to swallow oral medication;
  • haemoglobin ≥5.0 g/dL at admission;
  • informed consent from a parent or guardian;
  • parent/guardian agrees to bring the patient for planned follow-up visits at day 7, 14, 21, and 28

You may not qualify if:

  • general danger signs or signs of severe falciparum malaria according to the definitions of WHO;
  • severe malnutrition according to WHO child growth standards (WHO, 2006), children with marasmus or oedematous malnutrition;
  • mixed or mono-infection with another Plasmodium species detected by microscopy;
  • presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
  • regular medication, which may interfere with antimalarial pharmacokinetics;
  • history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
  • history of receiving any antimalarial treatment in the preceding 72 hours;. exposure to malaria vaccine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Makhonge Health Centre

Bungoma, Bungoma County, Kenya

Location

Kaluo Health Centre

Siaya, Siaya County, Kenya

Location

MeSH Terms

Interventions

Artemether, Lumefantrine Drug Combination

Intervention Hierarchy (Ancestors)

ArtemetherArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsLumefantrineFluorenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSesquiterpenesTerpenesPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The two drugs being assessed are already approved and in use by the Kenya Ministry of Health as the 1st and 2nd line treatments for malaria. The study is to assess the continued efficacy of the drugs.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2021

First Posted

February 23, 2021

Study Start

March 15, 2021

Primary Completion

December 18, 2022

Study Completion

December 18, 2022

Last Updated

November 1, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

KE(2)