NCT01213433

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2010

Shorter than P25 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

First Submitted

Initial submission to the registry

September 30, 2010

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2010

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

Enrollment Period

1 month

First QC Date

September 30, 2010

Last Update Submit

July 29, 2015

Conditions

Uncomplicated Malaria

Outcome Measures

Primary Outcomes (1)

  • Treatment failure at day 28

    28 days

Study Arms (1)

Amodiaquine+Artesunate

EXPERIMENTAL
Drug: Artesunate-Amodiaquine

Interventions

Artesunate-AmodiaquineDRUG

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)

Amodiaquine+Artesunate

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRUN

Nanoro, Boulkiemdé, 01, Burkina Faso

Location

MeSH Terms

Interventions

amodiaquine, artesunate drug combination

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PharmD, PhD

Study Record Dates

First Submitted

September 30, 2010

First Posted

October 4, 2010

Study Start

October 1, 2010

Primary Completion

November 1, 2010

Study Completion

April 1, 2011

Last Updated

July 31, 2015

Record last verified: 2015-07

Locations

BU(1)