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

Primary Purpose

Malaria

Status
Unknown status
Phase
Phase 4
Locations
Sudan
Study Type
Interventional
Intervention
Dihydroartemisinin- piperaquine
artemether- lumefantrine
Sponsored by
University of Khartoum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malaria focused on measuring antimalarials, ACTs, Piperaquine, uncomplicated

Eligibility Criteria

5 Years - 95 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Uncomplicated malaria

Exclusion Criteria:

  • Severe cases
  • Pregnancy

Sites / Locations

  • SinnarRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dihydroartemisinin- piperaquine

artemether- lumefantrine

Arm Description

orally tablets

oral tablets

Outcomes

Primary Outcome Measures

comparing the cure rate between the two drugs
PCR cure rate Parasite clearance time Fever clearance time

Secondary Outcome Measures

Full Information

First Posted
February 18, 2010
Last Updated
February 24, 2010
Sponsor
University of Khartoum
Collaborators
Southeast University, China
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1. Study Identification

Unique Protocol Identification Number
NCT01075945
Brief Title
Dihydroartemisinin- Piperaquine Versus Artemether- Lumefantrine in the Treatment Uncomplicated Plasmodium Falciparum Malaria in Sudan
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
April 2010 (Anticipated)
Study Completion Date
April 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Khartoum
Collaborators
Southeast University, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Dihydroartemisinin- Piperaquine is not inferior to artemether-lumefantrine

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
antimalarials, ACTs, Piperaquine, uncomplicated

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dihydroartemisinin- piperaquine
Arm Type
Experimental
Arm Description
orally tablets
Arm Title
artemether- lumefantrine
Arm Type
Active Comparator
Arm Description
oral tablets
Intervention Type
Drug
Intervention Name(s)
Dihydroartemisinin- piperaquine
Other Intervention Name(s)
Hoy-Cotec
Intervention Description
three tablets per day
Intervention Type
Drug
Intervention Name(s)
artemether- lumefantrine
Other Intervention Name(s)
Coartem
Intervention Description
twenty tablet in eight doses
Primary Outcome Measure Information:
Title
comparing the cure rate between the two drugs
Description
PCR cure rate Parasite clearance time Fever clearance time
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Uncomplicated malaria Exclusion Criteria: Severe cases Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ishag Adam, MD, PhD
Phone
+249912168988
Email
ishagadam@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fatih M Malik, MD
Phone
+249911259199
Email
ishagadamm@yahoo.com
Facility Information:
Facility Name
Sinnar
City
Cinnar
State/Province
Blue Nile
ZIP/Postal Code
11111
Country
Sudan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ishag Adam, Md, PhD
Phone
+249912168988
Email
ishagadam@hotmail.com
First Name & Middle Initial & Last Name & Degree
Fatih M Malik, MD
Phone
+249911259199
Email
ishagadamm@yahoo.com
First Name & Middle Initial & Last Name & Degree
Ishag I Adam, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
18718621
Citation
Adam I, Elmardi KA, Malik EM. Predictors of antimalarial treatment failure in an area of unstable malaria transmission in eastern Sudan. Trans R Soc Trop Med Hyg. 2009 Jan;103(1):21-4. doi: 10.1016/j.trstmh.2008.07.005. Epub 2008 Aug 20.
Results Reference
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Dihydroartemisinin- Piperaquine Versus Artemether- Lumefantrine in the Treatment Uncomplicated Plasmodium Falciparum Malaria in Sudan

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