NCT01094431

Brief Summary

The purpose of this study is to study the most common etiologies of uncomplicated fever diseases among children under five years of age in rural Zanzibar.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
690

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2011

Shorter than P25 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 26, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 29, 2010

Completed
1 year until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

3 months

First QC Date

March 26, 2010

Last Update Submit

December 2, 2014

Conditions

Keywords

FeverEtiologyChildren under five years of ageIMCI

Outcome Measures

Primary Outcomes (1)

  • relative frequency of febrile diseases etiology

    Five months

Eligibility Criteria

Age2 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Kivunge Primary Health Care Center (PHCC) in North A District in Zanzibar

You may qualify if:

  • Patients between 2-59 months of age with confirmed fever, with a measured axillary temperature of ≥37.5˚C, or history of fever within the preceding 24 hours.
  • Presenting at the health facility from 8.00 to 16.00 Monday to Friday.
  • Informed consent.
  • Able and willing to complete stipulated follow-up.

You may not qualify if:

  • Decision by the clinician to refer the patient to another health facility than the PHCC where the study is conducted.
  • Symptoms/ signs of severe disease that requires immediate referral from the PHCC as defined by the clinicians. These symptoms/signs of severe disease are according to the IMCI guidelines.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facility: Primary health care center (PHCC), Kivunge, North A district, Zanzibar

Kivunge, Zanzibar, Tanzania

Location

Related Publications (1)

  • Elfving K, Stromberg LG, Geravandi S, Andersson M, Bachelard M, Msellem M, Shakely D, Trollfors B, Norden R, Martensson A, Bjorkman A, Lindh M. Pneumococcal concentration and serotype distribution in preschool children with radiologically confirmed pneumonia compared to healthy controls prior to introduction of pneumococcal vaccination in Zanzibar: an observational study. BMC Infect Dis. 2022 Dec 10;22(1):925. doi: 10.1186/s12879-022-07902-5.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine collected in deep ager Frozen Nasopharyngeal secretions

MeSH Terms

Conditions

FeverCommunicable Diseases

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsInfectionsDisease AttributesPathologic Processes

Study Officials

  • Anders Björkman, Professor

    Karolinska University Hopsital

    PRINCIPAL INVESTIGATOR
  • Magnus Lindh, Professor

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR
  • Mwinyi Msellem, MSc

    Zanzibar Malaria Control Programme

    PRINCIPAL INVESTIGATOR
  • Abdullah S. Ali, Manager

    Zanzibar Malaria Control Programme

    PRINCIPAL INVESTIGATOR
  • Birger Trollfors, Professor

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR
  • Andreas Mårtensson, MD, PhD,

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR
  • Kristina Elfving, M.D.

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR
  • Deler Shakely, M.D.

    Karolinska University Hopsital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 26, 2010

First Posted

March 29, 2010

Study Start

April 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations