Efficacy and Safety of Prophylactic Use of an Antibiotic for Medical Thoracoscopy (APT)

A Study to Evaluate the Efficacy and Safety of a Single Dose of an Injectable Antibiotic for the Prophylaxis of Surgical Site and Pleural Space Infection After Medical Thoracoscopy

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.

Study Overview

• Status: Completed
• Conditions: Pleural Effusion; Pleurisy; Empyema
• Intervention / Treatment: Drug: Cefazolin; Other: saline

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160012
    • PGIMER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Other Names: Clindamycin
Placebo Comparator: 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.	Other: saline; 100 mL normal saline 15-30 minutes before the start of the procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy as assessed by occurrence of wound infection or pleural space infection	(a) Occurrence of wound infection as indicated by development of a purulent discharge from the surgical site or (b) pleural space infection as indicated by development of purulence, fall in sugar levels or gram's stain or culture positivity in the pleural fluid drained by the chest tube on the side of the procedure.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety as assessed by adverse effects	Adverse effects arising as a result of the antibiotic administered	7 days

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: May 9, 2015
• First Submitted That Met QC Criteria: May 13, 2015
• First Posted (Estimate): May 18, 2015

Study Record Updates

• Last Update Posted (Estimate): January 18, 2017
• Last Update Submitted That Met QC Criteria: January 16, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: pleural effusion; thoracoscopy; pleuroscopy; antibiotic prophylaxis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Inflammation; Pleural Diseases; Suppuration; Pleural Effusion; Empyema; Pleurisy; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Clindamycin; Cefazolin
• Other Study ID Numbers: NK/1816/Res/2440