NCT00608790

Brief Summary

The purpose of this study is to test whether a saline nebulization (breathing in a mist of moist air through a mask) will help an individual cough up a better sputum sample to test for tuberculosis (TB). In addition, this study will test whether samples obtained with saline nebulization are better at finding TB in people with HIV infection. The study will enroll up to 600 individuals, aged 12 and older, with suspected pulmonary TB. Participants will be asked to cough up a sample of sputum into a container. Then, participants will be asked to breathe a mist of moist air from an oxygen mask followed by moist salty air, which will help individuals to cough up a second sputum sample. This mist of moist air will contain salbutamol, a medicine to help open up the airways. The sputum samples will be sent to a laboratory to test for TB. Additionally, participants will be tested for HIV with a blood sample collection. Participants will be involved in study related procedures for up to 61 days.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 31, 2008

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 6, 2008

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

July 24, 2012

Status Verified

July 1, 2012

Enrollment Period

4.8 years

First QC Date

January 31, 2008

Last Update Submit

July 23, 2012

Conditions

Tuberculosis

Keywords

Tuberculosis, TB, Mycobacterium tuberculosis, children, South Africa

Outcome Measures

Primary Outcomes (1)

  • Sputum direct smear positive for acid-fast bacilli.

    Day 56 +

Secondary Outcomes (1)

  • Sputum culture positive for Mycobacterium tuberculosis.

    Day 56 +

Study Arms (1)

1

EXPERIMENTAL
Drug: SalbutamolDrug: Sodium chloride 5%

Interventions

SalbutamolDRUG

Prophylactic salbutamol administered at a dose of 200 micrograms by metered dose inhaler (MDI) via a spacer.

1
Sodium chloride 5%DRUG

30 ml sterile hypertonic saline solution (sodium chloride 5%) will be administered by jet nebulisation for 15-20 minutes.

1

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adolescents and adults with suspected pulmonary tuberculosis who are referred, or self-refer, to health services clinics for investigation for tuberculosis, will be eligible to participate.

You may not qualify if:

  • Failure to obtain informed consent (including failure to consent for either sputum collection procedures or failure to consent for HIV testing);
  • Age less than 12 years;
  • A history of asthma;
  • A history of heart disease;
  • A history of cardiac arrhythmia;
  • Inability to tolerate sputum induction procedures;
  • Inability to return for study follow-up visit;
  • Need for hospital-based in-patient treatment or supplemental oxygen therapy;
  • Other acute or chronic lung disease that may compromise lung function;
  • Current anti-tuberculous therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cape Town

Cape Town, South Africa

RECRUITING

Related Publications (1)

  • Geldenhuys HD, Whitelaw A, Tameris MD, Van As D, Luabeya KK, Mahomed H, Hussey G, Hanekom WA, Hatherill M. A controlled trial of sputum induction and routine collection methods for TB diagnosis in a South African community. Eur J Clin Microbiol Infect Dis. 2014 Dec;33(12):2259-66. doi: 10.1007/s10096-014-2198-4. Epub 2014 Jul 15.

    PMID: 25022447DERIVED

MeSH Terms

Conditions

Tuberculosis

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylamines

Study Officials

  • Mark Hatherill, MD, FCPaed

    University of Cape Town

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Hatherill

CONTACT

+27 21 4047618

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 31, 2008

First Posted

February 6, 2008

Study Start

February 1, 2008

Primary Completion

December 1, 2012

Study Completion

April 1, 2013

Last Updated

July 24, 2012

Record last verified: 2012-07

Locations

ZA(1)