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Amodiaquine+Artesunate for Uncomplicated Malaria Treatment (ASAQ-MAL)

Primary Purpose

Uncomplicated Malaria

Status

Completed

Phase

Phase 4

Locations

Burkina Faso

Study Type

Interventional

Intervention

Artesunate-Amodiaquine

About this trial

This is an interventional treatment trial for Uncomplicated Malaria

Eligibility Criteria

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

Inclusion Criteria:

Males and Females aged 6 months and above.
Body weight of 5 Kg and above.
RDT positive test.
Fever (axillary temperature at ≥ 37.5°C) or history of fever in the previous 24 hours.
Signed (or thumb-printed whenever patients are illiterate) informed consent.
Patients' willingness and ability to comply with the study protocol for the duration of the study.

Exclusion Criteria:

Participation in any other investigational drug study (antimalarial or others) during the previous 30 days.
Known hypersensitivity to the study drugs.
Severe malaria.
Danger signs: not able to drink or breast-feed, vomiting (> twice in 24hours), recent history of convulsions (>1 in 24h), unconscious state, unable to sit or stand.
Known intercurrent illness or any condition (cardiac, renal, hepatic diseases) which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study.
Severe malnutrition (defined as weight for height <70% of the median NCHS/WHO reference).

Sites / Locations

CRUN

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Amodiaquine+Artesunate

Arm Description

Outcomes

Primary Outcome Measures

Treatment failure at day 28

Secondary Outcome Measures

Full Information

NCT ID

NCT01213433

First Posted

September 30, 2010

Last Updated

July 29, 2015

Sponsor

Centre Muraz

Collaborators

Institute of Tropical Medicine, Belgium

1. Study Identification

Unique Protocol Identification Number

NCT01213433

Brief Title

Amodiaquine+Artesunate for Uncomplicated Malaria Treatment

Acronym

ASAQ-MAL

Official Title

Amodiaquine+Artesunate for the Treatment of Uncomplicated Falciparum Malaria in Nanoro, Burkina Faso

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centre Muraz

Collaborators

Institute of Tropical Medicine, Belgium

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a phase IV one-arm study aiming at recruiting 50 patients to assess the efficacy of AQ+AS in patients with a positive RDT diagnosis of malaria in Nanoro, Burkina Faso.

6. Conditions and Keywords

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

Uncomplicated Malaria

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Amodiaquine+Artesunate

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Artesunate-Amodiaquine

Intervention Description

Coformulated AQ+AS by Sanofi-Aventis has been pre-qualified by WHO in 2008.It is administered once daily for three consecutive days, and it is available in three different dosages (25mg/67.5mg; 50mg/135mg; 100mg/270mg)

Primary Outcome Measure Information:

Title

Treatment failure at day 28

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males and Females aged 6 months and above. Body weight of 5 Kg and above. RDT positive test. Fever (axillary temperature at ≥ 37.5°C) or history of fever in the previous 24 hours. Signed (or thumb-printed whenever patients are illiterate) informed consent. Patients' willingness and ability to comply with the study protocol for the duration of the study. Exclusion Criteria: Participation in any other investigational drug study (antimalarial or others) during the previous 30 days. Known hypersensitivity to the study drugs. Severe malaria. Danger signs: not able to drink or breast-feed, vomiting (> twice in 24hours), recent history of convulsions (>1 in 24h), unconscious state, unable to sit or stand. Known intercurrent illness or any condition (cardiac, renal, hepatic diseases) which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study. Severe malnutrition (defined as weight for height <70% of the median NCHS/WHO reference).

Facility Information:

Facility Name

CRUN

City

Nanoro

State/Province

Boulkiemdé

ZIP/Postal Code

Country

Burkina Faso

12. IPD Sharing Statement

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Amodiaquine+Artesunate for Uncomplicated Malaria Treatment

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