NCT01947075

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
538

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

August 21, 2014

Status Verified

August 1, 2014

Enrollment Period

1 year

First QC Date

September 13, 2013

Last Update Submit

August 20, 2014

Conditions

Keywords

FeverTanzaniaPneumoniaHIVDiabetesIndoor Air Pollution

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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.

    1 year

Other Outcomes (1)

  • Strength of association between each febrile disease and diabetes mellitus and between acute respiratory infections and indoor air pollution

    1 year

Study Arms (2)

Adults with fever

Every adult with fever will be screened for different infectious diseases and for nasopharyngeal respiratory viruses and bacteria

Healthy volonteers

For every adult with fever included with a diagnosis of pneumonia, a healthy volunteer will be included. These healthy volunteers will be screened for nasopharyngeal respiratory viruses and bacteria.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Every consecutive adult with temperature ≥38°C attending the outpatient department of Mwananyamala Hospital will be screened for inclusion. Additional inclusion criteria are fever of ≤1 week duration and first consultation for the present problem. Exclusion criteria are refusal of HIV screening, main complaint is injury or trauma, antibiotic treatment during the previous week (apart from cotrimoxazole prophylaxis), delivery within the previous 6 weeks and hospitalization during the last month. Medical history will be taken (including exposure to IAP) and clinical examination will be done in a standardized way.

You may qualify if:

  • Temperature \>=38°C
  • History of fever for less than 8 days
  • First consultation for the present problem

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mwananyamala Hospital

Dar es Salaam, Tanzania

Location

Related Publications (2)

  • Boillat-Blanco N, Klaassen B, Mbarack Z, Samaka J, Mlaganile T, Masimba J, Franco Narvaez L, Mamin A, Genton B, Kaiser L, D'Acremont V. Dengue fever in Dar es Salaam, Tanzania: clinical features and outcome in populations of black and non-black racial category. BMC Infect Dis. 2018 Dec 12;18(1):644. doi: 10.1186/s12879-018-3549-z.

  • Boillat-Blanco N, Mbarack Z, Samaka J, Mlaganile T, Mamin A, Genton B, Kaiser L, Calandra T, D'Acremont V. Prognostic value of quickSOFA as a predictor of 28-day mortality among febrile adult patients presenting to emergency departments in Dar es Salaam, Tanzania. PLoS One. 2018 Jun 14;13(6):e0197982. doi: 10.1371/journal.pone.0197982. eCollection 2018.

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood Serum Sputa Urine

MeSH Terms

Conditions

FeverPneumoniaDiabetes Mellitus

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Valerie D'Acremont, MD PhD

    Swiss Tropical & Public Health Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

September 13, 2013

First Posted

September 20, 2013

Study Start

July 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

August 21, 2014

Record last verified: 2014-08

Locations