NCT00451269

Brief Summary

The annual number of cases of clinical malaria worldwide is estimated to be 300-500 million leading to 1.5 million deaths. Delayed care and frequent drug resistance of Plasmodium falciparum (Pf), the most frequent form of malaria, is responsible for these deaths. Each year, 5000-8000 travellers return to France with malaria, 4/5 from Africa and with Pf. Clinical features associated with a malaria crisis are poorly predictive and misdiagnosis can be easily made. Diagnosis of accurate malaria rely on microscopic examination of stained thin and thick blood films by a well trained microscopist. Few emergency wards are specialized for tropical diseases. For most of them, malaria is a rare disease and hours are lost before accurate microscopy can permit the decision

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,297

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2007

Completed
9 days until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

February 21, 2011

Status Verified

March 1, 2007

Enrollment Period

2.8 years

First QC Date

March 21, 2007

Last Update Submit

February 18, 2011

Conditions

Malaria

Keywords

MalariaDiagnosisRDTpLDHHRP2Patients with fever and history of travel in a malariacountry

Interventions

Rapid diagnosis test for malariaDEVICE

Rapid diagnosis test for malaria

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Suspected malaria

You may qualify if:

  • No refusal by patient
  • Sample for malaria diagnosis

You may not qualify if:

  • Patient who do not want to participated to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital BICHAT CLAUDE BERNARD

Paris, 75018, France

Location

Related Publications (1)

  • Musset L, Bouchaud O, Matheron S, Massias L, Le Bras J. Clinical atovaquone-proguanil resistance of Plasmodium falciparum associated with cytochrome b codon 268 mutations. Microbes Infect. 2006 Sep;8(11):2599-604. doi: 10.1016/j.micinf.2006.07.011. Epub 2006 Aug 10.

    PMID: 16962361RESULT

MeSH Terms

Conditions

MalariaDisease

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sophie MATHERON, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 21, 2007

First Posted

March 23, 2007

Study Start

April 1, 2007

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

February 21, 2011

Record last verified: 2007-03

Locations

FR(1)