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

NCT02446782 | Completed Phase 4

• 1 other identifier: NK/1816/Res/2440
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pleural Effusion; Pleurisy; Empyema

Keywords

thoracoscopy; pleuroscopy; antibiotic prophylaxis; pleural effusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety as assessed by adverse effects

  7 days

Study Arms (2)

Cefazolin

EXPERIMENTAL

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

saline

PLACEBO COMPARATOR

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

Interventions

Cefazolin 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.

Also known as: Clindamycin

Cefazolin

saline OTHER

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

saline

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

PGIMER

Chandigarh, Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Pleural Effusion; Pleurisy; Empyema

Interventions

Cefazolin; Clindamycin; Sodium Chloride

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Infections; Suppuration; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Glycosides; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 9, 2015
• First Posted: May 18, 2015
• Study Start: January 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

IN (1)