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Multi-Centre Trial Comparing Three Artemisinin-Based Combination Treatments on P. Falciparum Malaria

Primary Purpose

Plasmodium Falciparum Malaria

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Co-Arinate FDC

Coartem

About this trial

This is an interventional treatment trial for Plasmodium Falciparum Malaria focused on measuring Open randomized multi-centre clinical trial in Africa, Uncomplicated P. falciparum malaria, Artemisinin-based Combination Therapy, Artesunate + sulfalene + pyrimethamine, 24 hour treatment, Artemether + lumefantrine

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

age at least 6 months,
weight at least 5 kg,
residing in one of the four countries (Mali, Cameroon, Sudan, Rwanda),
able to receive oral treatment,
having an axillary body temperature of more than 37,5 degrees Celsius or history of fever within the proceeding 24 hours,
suffering from a mono specific P. falciparum infection with a parasite density between 2000 and 200000 asexual forms per micro litre of blood.

Exclusion Criteria:

presence of severe or complicated malaria (WHO 2000),
severe concomitant pathology or one that needs a medical follow-up incompatible with the study,
allergic to one of the drugs involved in this study,
pregnant (reported pregnancy, detected clinically or with the β HCG test),
use of one of the anti-malaria drugs involved in this study during 28 days preceding inclusion.

Sites / Locations

Cameroon Baptist Convention Clinic of Biyem-Assi
Health centres of Samako, Kolle and Bancoumane
Health centres Rwamagana and Muhima
Alhara Alola Health centre

Outcomes

Primary Outcome Measures

PCR corrected Adequate Clinical and Parasitological Response

Early treatment failure

Late clinical failure

Late parasitological failure

Secondary Outcome Measures

Parasitic clearance

Fever clearance

Parasitological re-infection

Gametocyte carriage

Safety - Adverse events

Haemoglobin levels

Clinical and biological tolerance (Haemogram + Lever tests)

Full Information

NCT ID

NCT00484900

First Posted

June 8, 2007

Last Updated

March 25, 2008

Sponsor

Dafra Pharma

1. Study Identification

Unique Protocol Identification Number

NCT00484900

Brief Title

Multi-Centre Trial Comparing Three Artemisinin-Based Combination Treatments on P. Falciparum Malaria

Official Title

Open Randomized Multi-Centre Trial, Comparing Artesunate-Sulfamethoxypyrazine-Pyrimethamine FDC Over 3 Days, Artesunate-Sulfamethoxypyrazine-Pyrimethamine FDC Over 48 Hours and Artemether-Lumefantrine FDC Over 3 Days on P. Falciparum Malaria

Study Type

Interventional

2. Study Status

Record Verification Date

June 2007

Overall Recruitment Status

Completed

Study Start Date

May 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Dafra Pharma

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this open randomised multi-centre clinical trial is to test the hypothesis that three pills of the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine, administered over 24 hours is not inferior in efficacy to the same drug administered over 48 hours and that the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine As/SMP fdc, independently of the duration of its dose interval, is not inferior in efficacy to 6 - 24 pills (number of pills administered to respectively children and adults)of the 60 hours treatment of artemether/lumefantrine for the treatment of uncomplicated P. falciparum malaria.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Plasmodium Falciparum Malaria

Keywords

Open randomized multi-centre clinical trial in Africa, Uncomplicated P. falciparum malaria, Artemisinin-based Combination Therapy, Artesunate + sulfalene + pyrimethamine, 24 hour treatment, Artemether + lumefantrine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1390 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Co-Arinate FDC

Intervention Type

Drug

Intervention Name(s)

Coartem

Primary Outcome Measure Information:

Title

PCR corrected Adequate Clinical and Parasitological Response

Time Frame

on day 28 (follow-up period)

Title

Early treatment failure

Time Frame

between day 0 and day 3

Title

Late clinical failure

Time Frame

between day 4 and day 28

Title

Late parasitological failure

Time Frame

between day 7 and day 28

Secondary Outcome Measure Information:

Title

Parasitic clearance

Time Frame

28 day follow-up period

Title

Fever clearance

Time Frame

28 day follow-up period

Title

Parasitological re-infection

Time Frame

28 day follow-up period

Title

Gametocyte carriage

Time Frame

28 day follow-up period

Title

Safety - Adverse events

Time Frame

28 day follow-up period

Title

Haemoglobin levels

Time Frame

28 day follow-up period

Title

Clinical and biological tolerance (Haemogram + Lever tests)

Time Frame

28 day follow-up period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age at least 6 months, weight at least 5 kg, residing in one of the four countries (Mali, Cameroon, Sudan, Rwanda), able to receive oral treatment, having an axillary body temperature of more than 37,5 degrees Celsius or history of fever within the proceeding 24 hours, suffering from a mono specific P. falciparum infection with a parasite density between 2000 and 200000 asexual forms per micro litre of blood. Exclusion Criteria: presence of severe or complicated malaria (WHO 2000), severe concomitant pathology or one that needs a medical follow-up incompatible with the study, allergic to one of the drugs involved in this study, pregnant (reported pregnancy, detected clinically or with the β HCG test), use of one of the anti-malaria drugs involved in this study during 28 days preceding inclusion.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Issaka Sagara, Dr

Organizational Affiliation

University of Bamako, Mali

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Wilfred F Mbacham, Dr

Organizational Affiliation

University Yaoundé, Cameroon

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ishag A Adam, Dr

Organizational Affiliation

University of Khartoum, Sudan

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Stephen Rulisa, Dr

Organizational Affiliation

Kigali Central University Hospital, Rwanda

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cameroon Baptist Convention Clinic of Biyem-Assi

City

Yaounde

Country

Cameroon

Facility Name

Health centres of Samako, Kolle and Bancoumane

City

Bamako

Country

Mali

Facility Name

Health centres Rwamagana and Muhima

City

Kigali

Country

Rwanda

Facility Name

Alhara Alola Health centre

City

New Halfa

Country

Sudan

12. IPD Sharing Statement

Citations:

PubMed Identifier

19366448

Citation

Sagara I, Rulisa S, Mbacham W, Adam I, Sissoko K, Maiga H, Traore OB, Dara N, Dicko YT, Dicko A, Djimde A, Jansen FH, Doumbo OK. Efficacy and safety of a fixed dose artesunate-sulphamethoxypyrazine-pyrimethamine compared to artemether-lumefantrine for the treatment of uncomplicated falciparum malaria across Africa: a randomized multi-centre trial. Malar J. 2009 Apr 14;8:63. doi: 10.1186/1475-2875-8-63.

Results Reference

derived

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Multi-Centre Trial Comparing Three Artemisinin-Based Combination Treatments on P. Falciparum Malaria

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