Pulmonary InfectionsPhase 4PVAINNCT01356147

Dornase Alfa Therapy for Ventilator Associated Lung Infections in the Neonatal Intensive Care Unit (NICU)

A Phase 4 study testing Dornase alfa in people with Pulmonary Infections, run by Georgetown University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 7 days to 4 months
Conditions the study is for: Pulmonary Infections
What is being tested?: Dornase alfa
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 11 participants
Where: 2 sitesUnited States
Study dates: May 2011to 30 Apr 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 7 days to 4 months
All sexes
No healthy volunteers
Child

Who may be able to join

infants less than 38 weeks gestation and over 7 days of age
infants with a ventilator associated pulmonary infection, defined as intubated infants who have moderate to heavy White Blood Cells (WBCs) on tracheal aspirate, organisms on tracheal aspirate gram stain, a positive endotracheal tube culture, a chest x-ray with infiltrate, consolidation or atelectasis, an increase in oxygen (FiO2) requirement and whom the clinical team decides to treat with systemic antibiotic therapy

Who cannot join

Extremely ill infants not expected to survive
Critically ill infants requiring high frequency ventilation
Infants with congenital pneumonia
Infants with congenital malformations of the respiratory system (e.g. Congenital diaphragmatic hernia, cystic adenomatoid malformation or tracheo-esophageal fistula) Cyanotic congenital heart disease, chromosomal abnormalities and infants with a positive newborn screen for cystic fibrosis

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Georgetown University Hospital NICU
Washington D.C., District of Columbia, 20007
Georgetown University Hospital
Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: Pilot Study of Dornase Alfa (Pulmozyme) Therapy for Acquired Ventilator Associated Infection in Preterm and Late Preterm Infants in the Neonatal Intensive Care Unit

To evaluate the effect of Dornase alfa on preterm and late preterm neonates with ventilator associated pulmonary infections. Dornase alfa has been effective in the treatment of pulmonary infections in patients with cystic fibrosis by aiding mucus clearance. The bacteria causing pulmonary infections in cystic fibrosis patients is similar to those infecting preterm infants. The investigators expect that dornase alfa therapy will improve recovery from ventilator associated pulmonary infections in preterm infants.

Conditions: Pulmonary Infections
Being tested: Dornase alfa, Placebo
Keywords: ventilator associated pulmonary infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dornase alfaDrug
Also called Pulmozyme
2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation
PlaceboDrug
Also called Sham therapy
No therapy will be given to placebo arm

Study groups in NCT01356147
Study group	Role	What they receive
Sham placebo	Sham comparator	No therapy will be given to placebo arm. Respiratory therapist will shield infant from view and nebulize saline solution into incubator rather than into ventilator circuit. Receives: Drug: Placebo
Dornase alfa	Active comparator	Dornase alfa 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation Receives: Drug: Dornase alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Reduction in Oxygen Requirement From Baseline
Change in required supplemental oxygen from baseline or time to extubation from mechanical ventilation
Measured: First week of treatment or extubation

Secondary outcomes (2)

Elimination of White Blood Cells and Bacteria From Tracheal Aspirate
Number of infants with Tracheal aspirate WBC present on review of smear at end of therapy Bacterial load judged on presence of positive or negative culture in Tracheal aspirate
Measured: During first week of treatment or until extubation whichever is earlier
Number of Infants Requiring Ventilator Support
number of infants extubated during treatment/sham
Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 201130 Apr 2017

First posted19 May 2011 (estimated)
Study startMay 2011
Primary completionJan 2015
Study completion30 Apr 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pulmonary InfectionsStudies of the same condition, open and under way.
More trials run by Georgetown UniversityThe sponsor's other registered studies.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Care provider, Investigator, Outcomes assessor
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01356147
Sponsor's protocol ID: Z4962s
Acronym: PVAIN
Status last verified: Jul 2018
First submitted: 29 Mar 2011
Last updated: 7 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pulmonary Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study of Dornase Alfa (Pulmozyme) Therapy for Acquired Ventilator Associated Infection in Preterm and Late Preterm Infants in the Neonatal Intensive Care Unit
ClinicalTrials.gov ID: NCT01356147
Acronym / sponsor ID: PVAIN / Z4962s
Conditions: Pulmonary Infections
Keywords: ventilator associated pulmonary infections
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: Georgetown UniversityUniversity, hospital or other
Collaborators: Genentech, Inc.
Study start: May 2011
Primary completion: Jan 2015 (actual)
Study completion: 30 Apr 2017 (actual)
First posted: 19 May 2011 (estimated)
Results: Posted 8 Feb 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Sham placebo	Sham comparator	Drug: PlaceboNo therapy will be given to placebo arm. Respiratory therapist will shield infant from view and nebulize saline solution into incubator rather than into ventilator circuit.
Dornase alfa	Active comparator	Drug: Dornase alfaDornase alfa 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation

Who may qualify

Ages: 7 days to 4 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

infants less than 38 weeks gestation and over 7 days of age
infants with a ventilator associated pulmonary infection, defined as intubated infants who have moderate to heavy White Blood Cells (WBCs) on tracheal aspirate, organisms on tracheal aspirate gram stain, a positive endotracheal tube culture, a chest x-ray with infiltrate, consolidation or atelectasis, an increase in oxygen (FiO2) requirement and whom the clinical team decides to treat with systemic antibiotic therapy

Key exclusion criteria (4 listed)

Extremely ill infants not expected to survive
Critically ill infants requiring high frequency ventilation
Infants with congenital pneumonia
Infants with congenital malformations of the respiratory system (e.g. Congenital diaphragmatic hernia, cystic adenomatoid malformation or tracheo-esophageal fistula) Cyanotic congenital heart disease, chromosomal abnormalities and infants with a positive newborn screen for cystic fibrosis

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
Dornase alfaAlso: Pulmozyme2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation	Drug	Dornase alfa
PlaceboAlso: Sham therapyNo therapy will be given to placebo arm	Drug	Sham placebo

Primary outcome

Percent Reduction in Oxygen Requirement From Baseline
Time frame: First week of treatment or extubation
Change in required supplemental oxygen from baseline or time to extubation from mechanical ventilation

2 secondary outcomes

Elimination of White Blood Cells and Bacteria From Tracheal Aspirate
Time frame: During first week of treatment or until extubation whichever is earlier
Number of Infants Requiring Ventilator Support
Time frame: 7 days

Results and safety

Results posted to the registry on 8 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sham Placebo	5	5
Dornase Alfa	6	6

Primary outcome: Percent Reduction in Oxygen Requirement From Baseline

Time frame: First week of treatment or extubation. Mean (Full Range). Unit: percentage FiO2

Measure	Sham Placebo n = 5	Dornase Alfa n = 6
Value	5.4 (-2 to 23)	16.5 (-4 to 73)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: During 7 day period of drug or sham treatment then throughout NICU admission. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sham Placebo	0 of 5 (0%)	0 of 5 (0%)	Not reported
Dornase Alfa	0 of 6 (0%)	0 of 6 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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RecruitingObservational study
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A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
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Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
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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.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dornase alfa in people with Pulmonary Infections, run by Georgetown University at 2 sites in United States.

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 2 inclusion and 4 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 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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?

Yes. Results are posted in the registry (first posted 8 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent Reduction in Oxygen Requirement From Baseline (time frame: First week of treatment or extubation). 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 NCT01356147.

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 7 Aug 2018.