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Intravenous Artesunate and Malaria (IVAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01805232
Recruitment Status : Unknown
Verified March 2013 by Ishag Adam, University of Khartoum.
Recruitment status was:  Recruiting
First Posted : March 6, 2013
Last Update Posted : March 6, 2013
Sponsor:
Collaborators:
University of Kassala, Sudan
Kassala
Sudan
Information provided by (Responsible Party):
Ishag Adam, University of Khartoum

Study Description
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Brief Summary:
Intravenous artesunate is egual to quinine in the treatment of severe malaria

Condition or disease Intervention/treatment Phase
Malaria Drug: artesunate Drug: Quinine Phase 4

Detailed Description:
Intravenous artesunate is egual to quinine in the treatment of severe malaria in the form of fever clearance time and parasite clearance time
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravenous Artesunate Versus Quinine in Severe Malaria at Kassla, Sudan
Study Start Date : March 2013
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arms and Interventions
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Arm Intervention/treatment
Experimental: artesunate
intravenous artesunate 80 mg/kg initially then after 8 hours then daily
 Drug: artesunate
intravenous artesunate 80 mg/kg initially then after 8 hours then daily

Drug: Quinine
quinine infusion 80 mg/kg every 8 hours till the patient can take orally
Active Comparator: quinine
quinine infusion 80 mg/kg every 8 hours
 Drug: artesunate
intravenous artesunate 80 mg/kg initially then after 8 hours then daily

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


Outcome Measures
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Primary Outcome Measures :
  1. clearance of the parasite and fever [ Time Frame: 3 days ]
    To compare the parasite clearance time and fever clearance time between the two groups


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

severe P.falciparum malaria-

Exclusion Criteria:

mixed infection Pregnant women -

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01805232


Locations
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Sudan
Kassala Recruiting
Kassala, Sudan, 249
Contact: Abzinab A Ali, MD    +249911259199 ext 122    ishagadamm@yahoo.com   
Principal Investigator: Tajeldien A Abdulla, MD         
Sponsors and Collaborators
University of Khartoum
University of Kassala, Sudan
Kassala
Sudan
More Information
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Publications:

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Responsible Party: Ishag Adam, Professor, University of Khartoum
ClinicalTrials.gov Identifier: NCT01805232    
Other Study ID Numbers: artesunate and malaria
First Posted: March 6, 2013    Key Record Dates
Last Update Posted: March 6, 2013
Last Verified: March 2013
Keywords provided by Ishag Adam, University of Khartoum:
severe
Falciaparum
Malaria
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Infections
Vector Borne Diseases
Artesunate
Quinine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
 Antiviral Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents