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

NCT ID: NCT01075945

Last Updated: 2010-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Dihydroartemisinin- Piperaquine is not inferior to artemether-lumefantrine

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malaria

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

antimalarials ACTs Piperaquine uncomplicated

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dihydroartemisinin- piperaquine

orally tablets

Group Type EXPERIMENTAL

Dihydroartemisinin- piperaquine

Intervention Type DRUG

three tablets per day

artemether- lumefantrine

Intervention Type DRUG

twenty tablet in eight doses

artemether- lumefantrine

oral tablets

Group Type ACTIVE_COMPARATOR

artemether- lumefantrine

Intervention Type DRUG

twenty tablet in eight doses

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dihydroartemisinin- piperaquine

three tablets per day

Intervention Type DRUG

artemether- lumefantrine

twenty tablet in eight doses

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Hoy-Cotec Coartem

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Uncomplicated malaria

Exclusion Criteria

* Severe cases
* Pregnancy
Minimum Eligible Age

5 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Southeast University, China

OTHER

Sponsor Role collaborator

University of Khartoum

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Univeristy of Khartoum

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sinnar

Cinnar, Blue Nile, Sudan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Sudan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ishag Adam, MD, PhD

Role: CONTACT

Phone: +249912168988

Email: [email protected]

Fatih M Malik, MD

Role: CONTACT

Phone: +249911259199

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ishag Adam, Md, PhD

Role: primary

Fatih M Malik, MD

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 18718621 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DP v AL01aasudan

Identifier Type: OTHER

Identifier Source: secondary_id

wadadam

Identifier Type: -

Identifier Source: secondary_id

DP v AL01

Identifier Type: -

Identifier Source: org_study_id