Fungal ProphylaxisPhase 4NCT01495039
Antifungal Prophylaxis in Intensive Care Unit (ICU) Patients
A Phase 4 study testing Nystatin in people with Fungal Prophylaxis and Candida Infection, run by Policlinico Hospital at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fungal Prophylaxis, Candida Infection, Critical Illness
- What is being tested?
- Nystatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2008to Feb 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- surgical patients admitted to our ICU older than 18 years of age and expected to require invasive mechanical ventilation for more than 48 h.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Oral Nystatin Prophylaxis in ICU Surgical/Trauma 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.
Read the detailed description
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.
- Conditions
- Fungal Prophylaxis, Candida Infection, Critical Illness, Surgery
- Being tested
- Nystatin
- Medical subject headings
- Candidiasis, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NystatinDrug
Also called Mycostatin
Systematic nystatin prophylaxis (2 x 106 U per day administered three times daily in the naso-gastric tube)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Drug: Nystatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: At 15 day from ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2011 (estimated)
- Study startNov 2008
- Primary completionAug 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fungal ProphylaxisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filomena Puntillo, Policlinico Hospital
- Investigators
- Francesco Bruno, Professor, Study director, University of BariFilomena Puntillo, Professor, Principal investigator, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01495039
- Sponsor's protocol ID
- Nista 1
- Status last verified
- Apr 2017
- First submitted
- 12 Dec 2011
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22490643
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Oral Nystatin Prophylaxis in ICU Surgical/Trauma Patients
- ClinicalTrials.gov ID
- NCT01495039
- Acronym / sponsor ID
- Nista 1
- Conditions
- Fungal Prophylaxis, Candida Infection, Critical Illness, Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 19 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nystatin | Active comparator | Drug: Nystatinsurgical 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) |
| Control | Placebo comparator | Drug: Nystatinsurgical patients admitted to our ICU older than 18 years of age and expected to require invasive mechanical ventilation for more than 48 h. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- surgical patients admitted to our ICU older than 18 years of age and expected to require invasive mechanical ventilation for more than 48 h.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NystatinAlso: MycostatinSystematic nystatin prophylaxis (2 x 106 U per day administered three times daily in the naso-gastric tube) | Drug | Control, Nystatin |
Primary outcome
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.
1 secondary outcome
The secondary evaluation criterion will be the occurrence of a fungal infection during the ICU stay
Time frame: At 15 day from ICU admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
- Derived from this study: PubMed 22490643Giglio 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Bruno, Professor study director
University of Bari
Filomena Puntillo, Professor principal investigator
University of Bari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nystatin in people with Fungal Prophylaxis and Candida Infection, run by Policlinico Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
course of the colonization index over time. (time frame: AT 15 day from ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01495039, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2017.