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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01947075
Other study ID # Fever Study
Secondary ID Adult Fever Stud
Status Completed
Phase N/A
First received September 13, 2013
Last updated August 20, 2014
Start date July 2013
Est. completion date July 2014

Study information

Verified date August 2014
Source Swiss Tropical & Public Health Institute
Contact n/a
Is FDA regulated No
Health authority Tanzania: Ethical Committee
Study type Observational [Patient Registry]

Clinical Trial Summary

Following the decline of malaria in Sub-Saharan Africa, clinicians face febrile patients in whom an alternative diagnosis has to be made. This situation has led to an overuse of antibiotics by clinicians. It is crucial to increase knowledge on etiologies and risk factors of outpatient febrile illness in order to improve their management.

This present proposal aims to investigate the etiologies of fever among adult patients attending an outpatient department in urban Tanzania. It also aims to assess the clinical significance of nasopharyngeal (NP) respiratory viruses and bacteria documentation in this setting. Third, it aims to compare the spectrum of infections in this population with that of children included in the same setting in a previous study. The last objective is to assess diabetes mellitus (DM) as a risk factor for infection and exposure to indoor air pollution (IAP) as a risk factor for acute respiratory infections (ARI) in adults in Tanzania.

The investigators hypothesize that acute respiratory infections are the main cause of adult febrile illness in a urban low-income setting and that use of quantitative molecular assays on naso-oropharyngeal samples can improve the diagnosis of pneumonia. The investigators also think that the spectrum of infections is different between children and adults, mainly due to a high HIV prevalence in adults. The investigators also hypothesize that experiencing IAP and/ or DM is a risk factor for infections in adults.


Recruitment information / eligibility

Status Completed
Enrollment 538
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Temperature >=38°C

- History of fever for less than 8 days

- First consultation for the present problem

Exclusion Criteria:

- Refusal of HIV screening

- Main complaint is injury or trauma

- Antibiotic treatment in the last 7 days

- Within 6 weeks after delivery

- Hospitalization during the last month

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Tanzania Mwananyamala Hospital Dar es Salaam

Sponsors (2)

Lead Sponsor Collaborator
Swiss Tropical & Public Health Institute Ifakara Health Institute

Country where clinical trial is conducted

Tanzania, 

Outcome

Type Measure Description Time frame Safety issue
Other Strength of association between each febrile disease and diabetes mellitus and between acute respiratory infections and indoor air pollution Screening of diabetes mellitus and screening of exposure to indoor air pollution will be performed among patients with fever. The strength of association between diabetes and each type of febrile disease and exposure to indoor air pollution and acute respiratory infections will be measured. 1 year No
Primary Proportion of patients with each disease among all febrile patients, overall and stratified by HIV status Description of the distribution of causes of fever based on pre-defined case definitions for each disease. 1 year No
Secondary Proportion of febrile patients with acute respiratory infection infected with a certain respiratory pathogen, compared to the proportion of healthy controls infected with the same pathogen. Nasopharyngeal respiratory viruses and bacteria documentation (presence/absence as well as pathogen loads) will be compared between patients with acute respiratory infection and a control group of healthy volunteers 1 year No
See also
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Completed NCT03047642 - Validation of Promising Biomarker Assays to Assess Their Diagnostic Performance Characteristics