Artemisinin-Based Combination Therapy: Clinical Trials in Cameroon

NCT00297882 | Completed Phase 3 Results DMC

• 1 other identifier: ITCRVG46
• Study Type: interventional
• Target: 816
• Locations: 0 countries
• Sites: N/A

Brief Summary

This proposal aims to evaluate the safety and efficacy of artemisinin-based anti-malaria combination drugs (ACTs) for the treatment of children aged 6-120 months in different locations in Cameroon. Randomized clinical trials will provide local data on the safety of the test drugs, and on putative marker mutations of the development of resistance to ACT. The study will involve three centers, namely, Banso (Guinea-Savannah region), Limbe(Littoral Forest), and Garoua(Sahel-Savannah). The trial will compare the efficacy and safety of Amodiaquine(AQ)-Artesunate(Art) with Coartem®(Artemether-Lumefantrine). Drug efficacy will be determined using a WHO standardized 28-day protocol. Safety will be monitored through clinical examination and biochemical and hematological indices. Molecular markers of artemisinin resistance will be investigated by molecular sequencing and comparison of parasite profiles of the PfATP6 gene in drug failure cases, . Recrudescences or re-infections will be assessed by analysis of the msp1 and msp2 genes. The impact of these combinations on generation of gametocytes will be determined from gametocyte carriage rates measured by microscopy.

Conditions

Malaria

Keywords

Efficacy; Safety; Children; Cameroon

Outcome Measures

Primary Outcomes (1)

• Cure Rate on Day 28

  To evaluate the safety and antimalarial efficacy of two drug combinations: Artemether-Lumefantrine (AL) and Amodiaquine-Artesunate (AQ - AS) in Camaroonian patients in Mutengene, Bangolan and Garoua

  Day 0 - 28

Secondary Outcomes (1)

• Cure Rate Day 14

  Day 0-14

Study Arms (2)

1 Artemether-Lumefantrine (AL)

ACTIVE COMPARATOR

Study group 1. Subjects in this group received treatment with Artemether-Lumefantrine. Children received 2 mg/kg Artemether and 12 mg/kg Lumefrantrine with milk twice daily (or every 12 hours for 3 days.

Drug: 1. Artemether-Lumefantrine (AL)

2 Amodiaquine-Artesunate (AQ-AS)

ACTIVE COMPARATOR

Study group 2. Subjects in this group received treatment with Amodiaquine-Artesunate. Children received a co-administered combination of 30 mg/kg Amodiaquine (AQ) plus 4 mg/kg Artesunate (AS) daily for 3 days.

Drug: 2. Amodiaquine-Artesunate (AQ-AS)

Interventions

1. Artemether-Lumefantrine (AL) DRUG

Artemether-Lumefantrine(Co-Artem)=Artemether, 2mg/kg x 2(12h apart) and Lumefantrine, 12mg/kgx2 (12h apart).

Also known as: CoArtem

1 Artemether-Lumefantrine (AL)

2. Amodiaquine-Artesunate (AQ-AS) DRUG

Amodiaquine-Artesunate (0H),D1(24H),D2(48H)= Artesunate 4mg/kg and Amodiaquine at 10mg/kg

Also known as: Arsucam

2 Amodiaquine-Artesunate (AQ-AS)

Eligibility Criteria

• Age: 6 Months - 120 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children aged 6-120 months;
• axillary temperature ≥ 37.5°C and/or history of fever within past 24 hours;
• P. falciparum asexual parasitemia between 1000 and 100000/µl;
• ability to attend follow-up visits.

You may not qualify if:

• co-infections;
• underlying chronic disease;
• severe malaria as indicated by hyperparasitemia, severe anemia (PCV 15%, Hb 5g/ml), respiratory distress, inability to drink, persistent vomiting in past 24 hours;
• recent history of multiple convulsions;
• jaundice;
• the inability to stand or sit;
• history of allergy to study drugs.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• University of Yaounde: collaborator
• Cameroon Baptist Convention Health: collaborator

MeSH Terms

Conditions

Malaria

Interventions

Artemether, Lumefantrine Drug Combination

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

Limitations and Caveats

There were no limitations or caveats that prevented completion of the trial as planned

Results Point of Contact

• Title: Professor Wilfred Mbacham
• Organization: University of Yaounde 1, Cameroon

wfmbacham@yahoo.com

+237 677579180

Study Officials

• Wilfred F Mbacham, ScD

  University of Yaounde

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 28, 2006
• First Posted: March 1, 2006
• Study Start: July 1, 2006
• Primary Completion: April 1, 2009
• Study Completion: July 1, 2009
• Last Updated: June 8, 2021
• Results First Posted: June 8, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2013 and for 10 years
• Access Criteria: Database available on reqeust of Prof Wilfred Mbacham wfmbacham@yahoo.com