Dihydroartemisinin- Piperaquine Versus Artemether- Lumefantrine in the Treatment Uncomplicated Plasmodium Falciparum Malaria in Sudan

February 24, 2010 updated by: University of Khartoum
Dihydroartemisinin- Piperaquine is not inferior to artemether-lumefantrine

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sudan
    • Blue Nile
      • Cinnar, Blue Nile, Sudan, 11111
        • Recruiting
        • Sinnar
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ishag I Adam, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 95 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Uncomplicated malaria

Exclusion Criteria:

  • Severe cases
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dihydroartemisinin- piperaquine
orally tablets
Drug: Dihydroartemisinin- piperaquine
three tablets per day
Other Names:
  • Hoy-Cotec
Drug: artemether- lumefantrine
twenty tablet in eight doses
Other Names:
  • Coartem
Active Comparator: artemether- lumefantrine
oral tablets
Drug: artemether- lumefantrine
twenty tablet in eight doses
Other Names:
  • Coartem

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparing the cure rate between the two drugs
Time Frame: 3 months
PCR cure rate Parasite clearance time Fever clearance time
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Khartoum

Collaborators

Southeast University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Anticipated)

April 1, 2010

Study Completion (Anticipated)

April 1, 2010

Study Registration Dates

First Submitted

February 18, 2010

First Submitted That Met QC Criteria

February 24, 2010

First Posted (Estimate)

February 25, 2010

Study Record Updates

Last Update Posted (Estimate)

February 25, 2010

Last Update Submitted That Met QC Criteria

February 24, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DP v AL01
  • DP v AL01aasudan (Other Identifier: Holley)
  • wadadam

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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