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Etiology of Uncomplicated Fever in Children <5 in Rural Zanzibar (RDTNEG)

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ClinicalTrials.gov Identifier: NCT01094431
Recruitment Status : Completed
First Posted : March 29, 2010
Last Update Posted : December 3, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Fever Infectious Disease

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.

Study Design

Study Type : Observational
Actual Enrollment : 690 participants
Observational Model: Cohort
Official Title: Infectious Disease Etiologies of Uncomplicated Febrile Illness in Children <5 Years of Age in Rural Zanzibar
Study Start Date : April 2011
Primary Completion Date : July 2011
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. relative frequency of febrile diseases etiology [ Time Frame: Five months ]

Biospecimen Retention:   Samples Without DNA
Urine collected in deep ager Frozen Nasopharyngeal secretions

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Kivunge Primary Health Care Center (PHCC) in North A District in Zanzibar
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094431


Locations
Tanzania
Facility: Primary health care center (PHCC), Kivunge, North A district, Zanzibar
Kivunge, Zanzibar, Tanzania
Sponsors and Collaborators
Karolinska University Hospital
Zanzibar Malaria Control Programme
World Health Organization
Göteborg University
Queen Silvia Children's Hospital, Gothenburg, Sweden
Investigators
Principal Investigator: Anders Björkman, Professor Karolinska University Hopsital
Principal Investigator: Magnus Lindh, Professor Sahlgrenska University Hospital, Gothenburg, Sweden
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, Gothenburg, Sweden
Principal Investigator: Andreas Mårtensson, MD, PhD, Karolinska University Hospital
Principal Investigator: Kristina Elfving, M.D. Sahlgrenska University Hospital, Gothenburg, Sweden
Principal Investigator: Deler Shakely, M.D. Karolinska University Hopsital
More Information

Responsible Party: Anders Björkman, Professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01094431     History of Changes
Other Study ID Numbers: Fever 2010
First Posted: March 29, 2010    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by Anders Björkman, Karolinska University Hospital:
Fever
Etiology
Children under five years of age
IMCI

Additional relevant MeSH terms:
Fever
Communicable Diseases
Infection
Body Temperature Changes
Signs and Symptoms