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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003813
Receipt No. R000004601
Scientific Title Atovaquone-resistant Plasmodium falciparum in Central Africa
Date of disclosure of the study information 2010/07/23
Last modified on 2014/06/23

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Basic information
Public title Atovaquone-resistant Plasmodium falciparum in Central Africa
Acronym Atovaquone-resistant malaria
Scientific Title Atovaquone-resistant Plasmodium falciparum in Central Africa
Scientific Title:Acronym Atovaquone-resistant malaria
Region
Africa

Condition
Condition target disease - malaria
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To assess the current efficacy and tolerance of atovaquone-proguanil, compared with artesunate-amodiaquine, for the treatment of acute uncomplicated falciparum malaria
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes adequate clinical and parasitological response versus treatment failure on day 28, as defined by the World Health Organization
Key secondary outcomes parasite and fever clearance times

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 treatment with artesunate-amodiaquine (recommended by the national drug policy)
Interventions/Control_2 treatment with atovaquone-proguanil
Interventions/Control_3 treatment with artesunate-atovaquone-proguanil
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
4 months-old <=
Age-upper limit
60 months-old >=
Gender Male and Female
Key inclusion criteria fever at the time of consultation, presence of Plasmodium falciparum with a parasite density more than 2,000 asexual parasites per microlitre of blood
Key exclusion criteria signs and symptoms of severe and complicated malaria (as defined by the World Health Organization), mixed infections with other Plasmodium species, persistent vomiting, hematocrit less than 15%
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Leonardo Basco
Organization Institut de Recherche pour le Developpement
Division name Unite Mixte de Recherche 198
Zip code
Address Faculte de Medecine La Timone, Universite Aix-Marseille II, 27 boulevard Jean Moulin, 13385 Marseille, France
TEL 330491150149
Email lkbasco@yahoo.fr

Public contact
Name of contact person
1st name
Middle name
Last name Herve Tissot-Dupont
Organization Institut de Recherche pour le De;veloppement
Division name Departement Societes et Sante (DSS)
Zip code
Address Le Sextant, 44 boulevard de Dunkerque, CS90009, 13572 Marseille cedex 02, France
TEL 330491999570
Homepage URL http://www.ird.fr
Email dss@ird.fr

Sponsor
Institute Aix-Marseille Universite
Institute
Department

Funding Source
Organization Agence Nationale de la Recherche (ANR)
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization France

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions Nlongkak Catholic missionary dispensary, Yaounde, Cameroon

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 23 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2007 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 11 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
2011 Year 12 Month 01 Day
Date trial data considered complete
2011 Year 12 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 06 Month 23 Day
Last modified on
2014 Year 06 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004601

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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