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

Pleural Effusion Clinical Trial

— APT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02446782
• Other study ID #: NK/1816/Res/2440
• Status: Completed
• Phase: Phase 4
• First received: May 9, 2015
• Last updated: January 16, 2017
• Start date: January 2015
• Est. completion date: June 2016

Study information

• Verified date: January 2017
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Empyema
• Pleural Effusion
• Pleurisy

Intervention

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

Locations

Country	Name	City	State
India	PGIMER	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety as assessed by adverse effects	Adverse effects arising as a result of the antibiotic administered	7 days