NCT01390987

Brief Summary

Prompt access to care and treatment adherence are the hearth of tuberculosis control. This is a multicentre observational prospective study aimed at studying the factors associated with delayed access to care and low adherence to anti-tuberculosis treatment. Hetero- and self-administered questionnaires will be used at enrollment to assess clinical presentation and time and modalities of the diagnosis. Treatment adherence will be assessed during the follow-up with self administered questionnaires.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

6 active sites

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

June 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 7, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 20, 2014

Status Verified

January 1, 2014

Enrollment Period

1.3 years

First QC Date

July 7, 2011

Last Update Submit

January 17, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to TB diagnosis

    Study enrollment

Eligibility Criteria

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

All new tuberculosis (any site) diagnosed in the study time-frame, regardless of previous treatment history.

You may qualify if:

  • \>= 18 yrs of age
  • recent new TB diagnosis
  • Tuberculosis treatment prescribed
  • Ability to sign the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

AO Fallacara

Triggiano, BA, Italy

Location

Clinic of Infectious Diseases, AO San Gerardo

Monza, MB, 20900, Italy

Location

Clinica di Malattie Infettive, Spedali Civili

Brescia, 25126, Italy

Location

Clinica di Malattie Infettive, Ospedale San Martino

Genova, Italy

Location

Clinica di Malattie Infettive, Ospedale Luigi Sacco

Milan, Italy

Location

Clinica di Malattie Infettive, Policlinico Gemelli

Roma, Italy

Location

Related Publications (1)

  • Peri AM, Bernasconi DP, Galizzi N, Matteelli A, Codecasa L, Giorgio V, Di Biagio A, Franzetti F, Cingolani A, Gori A, Lapadula G. Determinants of patient and health care services delays for tuberculosis diagnosis in Italy: a cross-sectional observational study. BMC Infect Dis. 2018 Dec 20;18(1):690. doi: 10.1186/s12879-018-3609-4.

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Giuseppe Lapadula, MD, PhD

    Clinic of Infectious Disease, AO San Gerardo, Monza, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

July 7, 2011

First Posted

July 11, 2011

Study Start

June 1, 2011

Primary Completion

September 1, 2012

Study Completion

December 1, 2012

Last Updated

January 20, 2014

Record last verified: 2014-01

Locations