Etiology of Uncomplicated Fever in Children <5 in Rural Zanzibar (RDTNEG)
Recruitment status was Not yet recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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) |
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 |
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:
- 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| Contact: Anders Björkman, Professor | +46 8 51771866 | anders.bjorkman@karolinska.se |
| 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 | |
| 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 May 16, 2013