Antifungal Prophylaxis in Intensive Care Unit (ICU) Patients

NCT01495039 | Completed Phase 4 DMC

• 1 other identifier: Nista 1
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose. Oral chemoprophylaxis has been advocated to reduce the incidence of Candida colonization and infection. However, Candida prophylaxis in intensive care unit (ICU) is still a matter of debate. Methods. Randomized, single-center trial studying single drug (nystatin) versus control in surgical ICU patients. Multiple-site testing for fungi were performed in each patient at ICU admission (T0) and subsequently every 3 days (T3, T6, T9…). The primary evaluation criterion was the time course of colonization index (CI) during ICU stay.

Conditions

Fungal Prophylaxis; Candida Infection; Critical Illness; Surgery

Outcome Measures

Primary Outcomes (1)

• course of the colonization index over time.

  Fungal colonization will be defined as either the presence of the same yeast on one or more of the six distinct body sites tested (blood sample excepted), or on two consecutive specimens from the same body site. Candida Colonisation index (C.I.)was defined as the ratio of the number of distinct body sites colonised with genotypically identical strains of Candida spp (blood excepted) over the total number of sites tested.

  AT 15 day from ICU admission

Secondary Outcomes (1)

• The secondary evaluation criterion will be the occurrence of a fungal infection during the ICU stay

  At 15 day from ICU admission

Study Arms (2)

Nystatin

ACTIVE COMPARATOR

surgical patients admitted to our ICU older than 18 years of age and expected to require invasive mechanical ventilation for more than 48 h.Patients were allocated to receive systematic nystatin prophylaxis (2 x 106 U per day administered three times daily in the naso-gastric tube)

Drug: Nystatin

Control

PLACEBO COMPARATOR

surgical patients admitted to our ICU older than 18 years of age and expected to require invasive mechanical ventilation for more than 48 h.

Drug: Nystatin

Interventions

Nystatin DRUG

Systematic nystatin prophylaxis (2 x 106 U per day administered three times daily in the naso-gastric tube)

Also known as: Mycostatin

Control; Nystatin

Eligibility Criteria

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

You may qualify if:

• surgical patients admitted to our ICU older than 18 years of age and expected to require invasive mechanical ventilation for more than 48 h.

You may not qualify if:

• pregnancy,
• proven Candida infection,
• prophylactic or curative antifungal treatment within the last 2 months,
• contraindication to oral drug administration,

Sponsors & Collaborators

• Policlinico Hospital: lead

Study Sites (1)

Intensive care Unit, Policlinico Hospital Bari

Bari, Italy, 70100, Italy

Location

Related Publications (1)

• Giglio M, Caggiano G, Dalfino L, Brienza N, Alicino I, Sgobio A, Favale A, Coretti C, Montagna MT, Bruno F, Puntillo F. Oral nystatin prophylaxis in surgical/trauma ICU patients: a randomised clinical trial. Crit Care. 2012 Dec 12;16(2):R57. doi: 10.1186/cc11300.

  PMID: 22490643 DERIVED

MeSH Terms

Conditions

Candidiasis; Critical Illness

Interventions

Nystatin

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Francesco Bruno, Professor

  University of Bari

  STUDY DIRECTOR

• Filomena Puntillo, Professor

  University of Bari

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 12, 2011
• First Posted: December 19, 2011
• Study Start: November 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: February 1, 2010
• Last Updated: April 5, 2017

Record last verified: 2017-04

Locations

IT (1)