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Completed

NCT Number: NCT01495039

Antifungal Prophylaxis in Intensive Care Unit (ICU) Patients

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.

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Key information

Conditions

Fungal Prophylaxis Bacterial Infections and Mycoses Candida Infection Candidiasis Critical Illness Disease Attributes Infections Mycoses Pathologic Processes Pathological Conditions, Signs and Symptoms Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Intensive care Unit, Policlinico Hospital Bari

Bari, Italy, 70100

About this study

Multiple-site testing for fungi included: tracheal secretions, pharingael swab, stomach contents, rectal swab, groin skin fold swab, urine, and blood. These tests will be performed in each patient at ICU admission (T0) and subsequently every 3 days throughout the ICU stay (T3, T6, T9…), as routine in our ICU.The specimens were placed in a dry medium and taken to the Mycology Laboratory. Group assignment was not indicated on specimens, the mycologists were therefore blinded to treatment allocation.

Each specimen was directly microscopically examined and cultured on Sabouraud media.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • pregnancy,
  • proven Candida infection,
  • prophylactic or curative antifungal treatment within the last 2 months,
  • contraindication to oral drug administration,
  • known allergy to nystatin or its derivatives, and prior inclusion in the study

Treatment and study plan

Nystatin

Drug

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

Other names: Mycostatin

Primary outcomes

  1. course of the colonization index over time.

    Time frame: AT 15 day from ICU admission

    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.

Secondary outcomes

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

    Time frame: At 15 day from ICU admission

    Fungal infection will be defined as either the presence of a candidemia or the identification of Candida spp. in a normally sterile body site associated with a severe sepsis with negative tests for bacteria or other causes.

Sponsors and collaborators

Lead sponsor

Policlinico Hospital

Other

Registry information

Official study title

The Role of Oral Nystatin Prophylaxis in ICU Surgical/Trauma Patients

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Dec 19, 2011
Registry last updated
Apr 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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