NCT04897919

Brief Summary

Objective: to measure the effectiveness and safety of (artemether-lumefantrine) AL and (dihydroartemisinin-piperaquine) DP in patients (\> 6 months) suffering from uncomplicated P. falciparum malaria. Patients coming to Bandim Health Center will, if accepting, be randomised to study-arm. Medication will be provided and first dose given. Patients will be followed-up on day 7, 14, 28, and 42 with clinical evaluation, malaria film and filter-paper blood-sample for polumerase chain reaction (PCR) on re-appearing parasites. On day 21 and 35 a telephone-interview will be performed. Primary out-come: adequate clinical and parasitological response rate on day 42. Secondary out-comes: safety, re-infection vs recrudescence, and haemoglobin on day 42.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
474

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

August 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

May 24, 2021

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

2.2 years

First QC Date

August 31, 2015

Last Update Submit

April 7, 2022

Conditions

MalariaEffectiveness

Outcome Measures

Primary Outcomes (1)

  • Adequate clinical and parasitological response rate at day 42

    Cumulative percentages of children having successful treatment on day 42.

    Day 42

Secondary Outcomes (2)

  • re-infection vs recrudescence

    Day 42

  • Haemoglobin level

    Day 42

Study Arms (2)

dihydroartemisinin-piperaquine

EXPERIMENTAL

First dose will be given supervised. The rest will be provided and the parents should take it at home. Dihydroartemisinin-piperaquine dosing as recommended by manufacturer

Drug: Dihydroartemisinin-piperaquine 160 mg/20 mg Oral Tablet

artemether-lumefantrine

ACTIVE COMPARATOR

First dose will be given supervised. The rest will be provided and the patients should take it at home. Artemether-lumefantrine dosing as recommended by manufacturer

Drug: Artemether-Lumefantrine 20 Mg-120 Mg Oral Tablet

Interventions

Dihydroartemisinin-piperaquine 160 mg/20 mg Oral TabletDRUG

Dihydroartemisinin-piperaquine is given as recommended by manufacturer and compared to the Artemether-lumefantrine group.

Also known as: Eurartesim
dihydroartemisinin-piperaquine
Artemether-Lumefantrine 20 Mg-120 Mg Oral TabletDRUG

Artemether-Lumefantrine is given as recommended by manufacturer

Also known as: Coartem
artemether-lumefantrine

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Mono-infection with P. falciparum detected by microscopy.
  • Parasitemia of 1.000-200.000/µl asexual forms.
  • Axillary temperature ≥37.5 ˚C or a history of fever within 24 hours.
  • Ability to swallow oral medication.
  • Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule.
  • Informed consent

You may not qualify if:

  • Signs or symptoms of severe malaria
  • Presence of general danger signs in children under 5
  • Presence of severe malnutrition.
  • Any evidence of chronic disease or acute infection other than malaria.
  • Regular medication which may interfere with antimalarial pharmacokinetics.
  • History of hypersensitivity reactions or contraindications to AL, DP or quinine.
  • Domicile outside the study area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bandim Health Centre

Bissau, Bissau Codex, Guinea-Bissau

Location

MeSH Terms

Conditions

Malaria

Interventions

TabletsArtemether, Lumefantrine Drug Combination

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical PreparationsArtemetherArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsLumefantrineFluorenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSesquiterpenesTerpenesPolycyclic CompoundsDrug Combinations

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2015

First Posted

May 24, 2021

Study Start

August 1, 2015

Primary Completion

October 1, 2017

Study Completion

December 1, 2018

Last Updated

April 12, 2022

Record last verified: 2022-04

Locations

GU(1)