UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003813
Receipt number 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 17:05:46

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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 or person

Institute

Aix-Marseille Universite

Institute

Department

Personal name



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

Value
https://center6.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