Amodiaquine+Artesunate for Uncomplicated Malaria Treatment | NCT01213433

Studies
Amodiaquine+Artesunate for Uncomplicated Malaria Treatment

NCT01213433

Sponsor

Centre Muraz

Status

Completed

Last Update Posted

Jul 31, 2015Estimated

Enrollment

150Actual

Phase

Phase 4

Conditions

Uncomplicated Malaria

Interventions

Artesunate-Amodiaquine

Countries

Burkina Faso

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Nov 2010Actual

Completion Date

Apr 2011Actual

First Submitted Date

Sep 30, 2010

First Submission Date that Met QC Criteria

Oct 1, 2010

First Posted Date

Oct 4, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2015

Last Update Posted Date

Jul 31, 2015Estimated

Name	Class
Institute of Tropical Medicine, Belgium	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Amodiaquine+Artesunate	Experimental		Drug: Artesunate-Amodiaquine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Artesunate-Amodiaquine	Drug	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)

Measure	Description	Time Frame
Treatment failure at day 28		28 days

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided