NCT01027832

Brief Summary

Mechanically Ventilated patients in the intensive care unit (ICU) often present with fever, and purulent sputum, but without radiological evidence of pneumonia. These patients may have tracheobronchitis. Some suspect that this condition precedes the development of pneumonia. Antibiotic treatment in tracheobronchitis is controversial. The investigators will recruit patients with tracheobronchitis and randomize them into 2 groups. One group will be treated with antibiotics and the other group will serve as control.

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
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2009

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

Study Start

First participant enrolled

September 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2009

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

December 9, 2009

Status Verified

December 1, 2009

Enrollment Period

1 year

First QC Date

November 26, 2009

Last Update Submit

December 8, 2009

Conditions

Tracheobronchitis

Keywords

tracheobronchitis

Outcome Measures

Primary Outcomes (1)

  • Rate of development of new pneumonia

    2 years

Secondary Outcomes (1)

  • ICU length of stay (LOS) and mortality

    2 years

Study Arms (2)

Control arm

NO INTERVENTION

no intervention

Experimental arm

EXPERIMENTAL

antibiotics

Drug: Piperacillin/Tazobactam for 7 days

Interventions

Piperacillin/Tazobactam for 7 daysDRUG

Piperacillin/Tazobactam for 7 days

Experimental arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Tracheobronchitis as defined by:
  • Purulent sputum with \> 10 x 4 CFU
  • Leukocytosis or leukopenia
  • Fever
  • No pneumonia on CT scan

You may not qualify if:

  • Recent treatment of pneumonia
  • Abnormal Chest X-ray
  • Evidence of Pneumonia on CT scan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf Harofe MC

Beer Yakov, Zerifin, 70300, Israel

RECRUITING

MeSH Terms

Interventions

PiperacillinTazobactam

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPenicillanic AcidSulfones

Study Officials

  • Arie Soroksky, MD

    Tel Aviv University, Faculty of Medicine, Israel.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arie Soroksky, MD

CONTACT

972-8-9779320soroksky@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 26, 2009

First Posted

December 9, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2011

Last Updated

December 9, 2009

Record last verified: 2009-12

Locations

IL(1)