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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Karolinska University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Zanzibar Malaria Control Programme
World Health Organization
Göteborg University
Queen Silvia Children's Hospital, Gothenburg,. Sweden
Information provided by:
Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01094431
First received: March 26, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

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
Fever
Infectious Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Infectious Disease Etiologies of Uncomplicated Febrile Illness in Children <5 Years of Age in Rural Zanzibar

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • relative frequency of febrile diseases etiology [ Time Frame: Five months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Urine collected in deep ager Frozen Nasopharyngeal secretions


Estimated Enrollment: 500
Study Start Date: May 2010
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   2 Months to 59 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01094431

Contacts
Contact: Anders Björkman, Professor +46 8 51771866 anders.bjorkman@karolinska.se

Locations
Tanzania
Facility: Primary health care center (PHCC), Kivunge, North A district, Zanzibar Recruiting
Kivunge, Zanzibar, Tanzania
Contact: Rahila Omar, C.O.    +255(0)777424862    omarrs67@yahoo.com   
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

No publications provided

Responsible Party: Professor Anders Björkman, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01094431     History of Changes
Other Study ID Numbers: Fever 2010
Study First Received: March 26, 2010
Last Updated: March 26, 2010
Health Authority: Regional Ethical Committee, Stockholm, Sweden:
MOH Research Council, Zanzibar, Tanzania:

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

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

ClinicalTrials.gov processed this record on August 20, 2014