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CompletedNCT01094431RDTNEGUpdated Dec 3, 2014

Etiology of Uncomplicated Fever in Children <5 in Rural Zanzibar

An observational study in Fever and Infectious Disease, sponsored by Karolinska University Hospital. Completed at 1 site in Tanzania. Open to participants aged 2 Months to 59 Months. Per ClinicalTrials.gov, last updated 2014-12-03.

Sponsored by Karolinska University Hospital · Observational

Study type
Observational
Model
Cohort
Enrollment
690
Ages
2 Months to 59 Months
Sex
All
01

Study 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.

Read the detailed description

During the last 6 years Zanzibar has undergone a dramatic change in malaria epidemiology and burden of disease, with a marked decline of Plasmodium falciparum malaria among febrile children from approximately 30% to 1% or below and a reduction of crude child mortality of 50%. Millions of children in Africa die of neonatal disorders, acute respiratory tract infections (ARI), diarrhea, malaria, measles, HIV and malnutrition. A majority of these illnesses are also a common cause of febrile illness in out-patient departments. However, most of the few fever studies made in Africa are hospital based Very few studies on etiology of childhood febrile disease have been conducted on first level health facilities in the least developed countries in Africa. This study will therefore focus on children between 2 months to 5 years of age that have been diagnosed with a negative rapid diagnostic test (RDT) for malaria and their causes of fever at the first referral level in out-patient clinics in Zanzibar.

02

Conditions studied

  • Fever
  • Infectious Disease

Keywords

  • Fever
  • Etiology
  • Children under five years of age
  • IMCI
03

In context

Communicable Diseases

4,452 studies on the registry are indexed under Communicable Diseases; 521 are open to participants now.

This study's enrollment of 690 is above the median of 244 across 1,499 observational studies indexed under Communicable Diseases.

Browse Communicable Diseases studies →

Lead sponsor

Karolinska University Hospital is the lead sponsor of 275 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
2 Months to 59 Months
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Enrollment
690 participants (actual)
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. relative frequency of febrile diseases etiology

    Time frame: Five months

07

Study locations

1 site
  • Facility: Primary health care center (PHCC), Kivunge, North A district, Zanzibar
    Kivunge, Zanzibar, Tanzania
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01094431
Lead sponsor
Karolinska University Hospital
Collaborators
Zanzibar Malaria Control Programme, World Health Organization, Göteborg University, Queen Silvia Children's Hospital, Gothenburg, Sweden
Responsible party
Anders Björkman (Professor, Karolinska University Hospital) — Principal investigator
First posted
Mar 29, 2010
Start date
Apr 2011
Primary completion
Jul 2011
Completion
Jul 2011
Last update
Dec 3, 2014

Study contacts

Anders Björkman, Professor
principal investigator · Karolinska University Hopsital
Magnus Lindh, Professor
principal investigator · Sahlgrenska University Hospital
Mwinyi Msellem, MSc
principal investigator · Zanzibar Malaria Control Programme
Abdullah S. Ali, Manager
principal investigator · Zanzibar Malaria Control Programme
Birger Trollfors, Professor
principal investigator · Sahlgrenska University Hospital
Andreas Mårtensson, MD, PhD,
principal investigator · Karolinska University Hospital
Kristina Elfving, M.D.
principal investigator · Sahlgrenska University Hospital
Deler Shakely, M.D.
principal investigator · Karolinska University Hopsital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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