Study to Investigate the Causes of Fever in Children Livi... | NCT01812785

Studies
Study to Investigate the Causes of Fever in Children Living in Urban Dar es Salaam and Rural Ifakara

NCT01812785

Sponsor

Swiss Tropical & Public Health Institute

Status

Completed

Last Update Posted

Mar 18, 2013Estimated

Enrollment

1,010Actual

Phase

Not provided

Conditions

Fever
Children
Infectious Diseases

Interventions

Not provided

Countries

Tanzania

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
SNSF	Other Grant/Funding Number	SNSF grants # 3270B0-109696 and # IZ70Z0-124023

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2011Actual

First Submitted Date

Mar 14, 2013

First Submission Date that Met QC Criteria

Mar 14, 2013

First Posted Date

Mar 18, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2013

Last Update Posted Date

Mar 18, 2013Estimated

Name	Class
University Hospital, Geneva	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal is to improve the evidence-based management of fever cases seen in outpatient clinics in malaria endemic countries, through a better understanding of the value of accurate malaria diagnosis, and through an improved understanding of the other causes of fever in children. The objective is to describe systematically (as much as possible) the etiologies of fever in children in an urban and in a rural environment of sub-Saharan Africa.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,010Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of each disease and proportion of fevers of unknown origin in febrile children aged 2 months to 10 years attending an Outpatient Department of a district hospital in Dar es Salaam and in Ifakara		December 2011

Secondary Outcomes

Measure	Description	Time Frame
Clinical and laboratory predictors of each disease		December 2011

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

axillary temperature of 38°C or more
first consultation for the present problem
history of fever lasting for one week or less
main complaint was not an injury or trauma
no report of an antimalarial or antibiotic medicine taken during the previous week

Exclusion Criteria:

severe malnutrition
categorized as P1 (requiring immediate live saving procedures)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Months

Maximum Age

10 Years

Standard Ages

Child

Study Population

Consecutive patients aged 2 months to 10 years presenting at the outpatient clinic of Amana district hospital in Dar es Salaam, and at the outpatient clinic of St-Francis designated-district hospital in Ifakara, Kilombero District.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Blaise Genton, prof	Swiss Tropical & Public Health Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Amana district hospital		Dar es Salaam	Dar es Salaam Region		Tanzania
St Francis hospital

Condition Browse Module

MeSH Terms

ID	Term
D005334	Fever
D003141	Communicable Diseases
D004194	Disease

Ancestor Terms

ID	Term
D001832	Body Temperature Changes
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided