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Etiology of Uncomplicated Fever in Children <5 in Rural Zanzibar

NCT ID: NCT01094431

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

690 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fever Infectious Disease

Study Design

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Observational Model Type

COHORT

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

2 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zanzibar Malaria Control Programme

OTHER_GOV

Sponsor Role collaborator

World Health Organization

OTHER

Sponsor Role collaborator

Göteborg University

OTHER

Sponsor Role collaborator

Queen Silvia Children's Hospital, Gothenburg, Sweden

OTHER

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anders Björkman

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anders Björkman, Professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hopsital

Magnus Lindh, Professor

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Mwinyi Msellem, MSc

Role: PRINCIPAL_INVESTIGATOR

Zanzibar Malaria Control Programme

Abdullah S. Ali, Manager

Role: PRINCIPAL_INVESTIGATOR

Zanzibar Malaria Control Programme

Birger Trollfors, Professor

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Andreas Mårtensson, MD, PhD,

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Kristina Elfving, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Deler Shakely, M.D.

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hopsital

Locations

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

Kivunge, Zanzibar, Tanzania

Site Status

Countries

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Tanzania

References

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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.

Reference Type DERIVED
PMID: 36496395 (View on PubMed)

Other Identifiers

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Fever 2010

Identifier Type: -

Identifier Source: org_study_id