Completed

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

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What is being tested

Nystatin

Drug
Who is being recruted

Bacterial Infections and Mycoses+5

+ Candidiasis

+ Infections

Over 18 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledPhase 4
Interventional
Study Start: November 2008
See protocol details

Summary

Principal SponsorPoliclinico Hospital
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2008

Actual date on which the first participant was enrolled.

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.

Official TitleThe Role of Oral Nystatin Prophylaxis in ICU Surgical/Trauma Patients
NCT01495039
Principal SponsorPoliclinico Hospital
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

99 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bacterial Infections and MycosesCandidiasisInfectionsMycosesPathologic ProcessesPathological Conditions, Signs and SymptomsCritical IllnessDisease Attributes

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

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)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Intensive care Unit, Policlinico Hospital Bari

Bari, ItalyOpen Intensive care Unit, Policlinico Hospital Bari in Google Maps
CompletedOne Study Center