Intravenous Artesunate and Malaria

NCT ID: NCT01805232

Last Updated: 2013-03-06

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-07-31

Brief Summary

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Intravenous artesunate is egual to quinine in the treatment of severe malaria

Detailed Description

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Intravenous artesunate is egual to quinine in the treatment of severe malaria in the form of fever clearance time and parasite clearance time

Conditions

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Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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artesunate

intravenous artesunate 80 mg/kg initially then after 8 hours then daily

Group Type EXPERIMENTAL

artesunate

Intervention Type DRUG

intravenous artesunate 80 mg/kg initially then after 8 hours then daily

Quinine

Intervention Type DRUG

quinine infusion 80 mg/kg every 8 hours till the patient can take orally

quinine

quinine infusion 80 mg/kg every 8 hours

Group Type ACTIVE_COMPARATOR

artesunate

Intervention Type DRUG

intravenous artesunate 80 mg/kg initially then after 8 hours then daily

Quinine

Intervention Type DRUG

quinine infusion 80 mg/kg every 8 hours till the patient can take orally

Interventions

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artesunate

intravenous artesunate 80 mg/kg initially then after 8 hours then daily

Intervention Type DRUG

Quinine

quinine infusion 80 mg/kg every 8 hours till the patient can take orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

severe P.falciparum malaria-

Exclusion Criteria

mixed infection Pregnant women -
Minimum Eligible Age

1 Year

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kassala, Sudan

OTHER

Sponsor Role collaborator

Kassala

UNKNOWN

Sponsor Role collaborator

Sudan

UNKNOWN

Sponsor Role collaborator

University of Khartoum

OTHER

Sponsor Role lead

Responsible Party

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Ishag Adam

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kassala

Kassala, Kassala, Sudan

Site Status RECRUITING

Countries

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Sudan

Facility Contacts

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Abzinab A Ali, MD

Role: primary

+249911259199 ext. 122

References

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Eltahir HG, Omer AA, Mohamed AA, Adam I. Comparison of artesunate and quinine in the treatment of Sudanese children with severe Plasmodium falciparum malaria. Trans R Soc Trop Med Hyg. 2010 Oct;104(10):684-6. doi: 10.1016/j.trstmh.2010.05.009. Epub 2010 Jun 17.

Reference Type BACKGROUND
PMID: 20850004 (View on PubMed)

Other Identifiers

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artesunate and malaria

Identifier Type: -

Identifier Source: org_study_id

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