Efficacy and Safety of Prophylactic Use of an Antibiotic for Medical Thoracoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-06-30

Brief Summary

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This is a prospective study to assess the efficacy and safety of a single dose of cefazolin 2g IV for the prophylaxis of surgical site and pleural space infections in patients undergoing medical thoracoscopy.

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Detailed Description

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This is a prospective randomized study to assess the efficacy and safety of a single dose of cefazolin 2g IV for the prophylaxis of surgical site and pleural space infections during medical thoracoscopy.

Consecutive patients who are planned to undergo a medical thoracoscopy (rigid or semirigid) will be enrolled in the study if they satisfy the inclusion and exclusion criteria. One hundred patients will be randomized in 1:1 ratio to receive either of the following: (a) A single dose of intravenous cefazolin 2 gms dissolved in 100 mL of normal saline administered over 10 minutes, between 15 and 30 minutes before the incision, OR (b) 100 mL normal saline administered intravenously over a period of 10 minutes between 15 and 30 minutes before the incision. Thoracoscopy will be performed in the bronchoscopy suite on a spontaneously breathing subject (fasting for 8 h) under conscious sedation (using midazolam, pentazocine, and tramadol) observing complete aseptic precautions.

Conditions

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Pleural Effusion Pleurisy Empyema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cefazolin

A single dose of intravenous cefazolin 2 gms will be administered over 10 minutes, dissolved in 100 mL of normal saline between 15 and 30 minutes before the incision. This will be preceded by an intradermal test dose to check for hypersensitivity to the drug. If hypersensitivity is present, the patient will be administered a single dose of intravenous Clindamycin 900 mg.

Group Type EXPERIMENTAL

Cefazolin

Intervention Type DRUG

Cefazolin 2 gm administered in 100 mL normal saline (after skin sensitivity testing) 15-30 minutes before the start of the procedure. Clindamycin 900 mg to be administered if sensitivity detected to cefazolin.

saline

100 mL normal saline will be administered intravenously over a period of 10 minutes between 15 and 30 minutes before the incision. An intradermal test dose with normal saline will be administered to this group.

Group Type PLACEBO_COMPARATOR

saline

Intervention Type OTHER

100 mL normal saline 15-30 minutes before the start of the procedure

Interventions

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Cefazolin

Cefazolin 2 gm administered in 100 mL normal saline (after skin sensitivity testing) 15-30 minutes before the start of the procedure. Clindamycin 900 mg to be administered if sensitivity detected to cefazolin.

Intervention Type DRUG

saline

100 mL normal saline 15-30 minutes before the start of the procedure

Intervention Type OTHER

Other Intervention Names

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Clindamycin

Eligibility Criteria

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Inclusion Criteria

1. Age ≥12 years
2. Medical thoracoscopy being performed for a pleural effusion for any of the three indications: diagnosis, pleurodesis, or adhesiolysis

Exclusion Criteria

1. Age ≥80 years
2. Pao2/FIO2\< 300;
3. Hemodynamic instability
4. Myocardial infarction or unstable angina in the last 6 wk
5. Lack of pleural space due to adhesions
6. Uncorrected coagulopathy
7. Failure to provide informed consent
8. Patients already taking any antibiotic due to any reason

Minimum Eligible Age

12 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No