Pulmonary Fungal InfectionPhase 4NCT01823289

An Efficacy and Safety Study of Itraconazole Sequential Therapy (Intravenous Injection Followed by Oral Solution) in Invasive Pulmonary Fungal Infections

A Phase 4 study testing Itraconazole in people with Pulmonary Fungal Infection, run by Xian-Janssen Pharmaceutical Ltd..

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

The purpose of this study is to evaluate the efficacy and safety of itraconazole sequential therapy (intravenous injection/oral solution) in participants with invasive pulmonary fungal infections ([IPFI]; lung diseases caused by fungal infection). Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Pulmonary Fungal Infection
What is being tested?: Itraconazole
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 71 participants
Where: No sites listed yet
Study dates: Jun 2007to Jan 2009
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 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Probable or proven invasive pulmonary infectious participants (IPFI) - Hospitalized participants (at least hospitalized treatment and observation could be ensured during the intravenous injection period) - The participants (or legal representatives) have signed the informed consent forms.

Who cannot join

Currently taking taboo drugs, such as terfenadine, astemizole, cisapride and HMG CoA reductase inhibitors (for example simvastatin, lovastatin, oral or intravenous midazolam or triazolam) - History of allergy or intolerance to imidazoles or pyrrole drugs (for example fluconazole, itraconazole, ketoconazole, miconazole, clotrimazole) - Pregnant and breast feeding women, or women of child bearing age not taking effective contraception measures - Participants with pure oral, urinary tract, and vaginal candidiasis (yeast infection) - Participants with fungal meningitis (inflammation of the meninges), active liver disease, renal insufficiency with the serum creatinine clearance rate less than 30 milliliter per minute (ml/min), and current abnormal cardiac function such as congestive heart failure (condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body), or participants with history of congestive heart failure

About this study

Official title: Clinical Efficacy and Safety of Itraconazole Injection/Oral Solution Sequential Therapy for Treatment of Invasive Pulmonary Fungal Infections

Read the detailed description

This is an open-label (all people know the identity of the intervention), single arm, multicenter (when more than one hospital or medical school team work on a medical research study) study to evaluate the efficacy and safety of itraconazole sequential therapy in participants with IPFI. The study duration will be 4 to 6 weeks. The treatment will be divided into the intravenous (into a vein) injection period and the oral solution administration (giving) period. During the intravenous injection period 200 milligram (mg) twice daily loading dose (large initial dose) will be given for first 2 days, 200 mg once daily for the subsequent 12 days. Then sequential itraconazole oral solution 200 mg twice daily will be given as maintenance therapy (treatment designed to help the original primary treatment to succeed) for 2-4 weeks. Participant's clinical, mycological and comprehensive efficacy will be assessed at Week 6. Participants' safety will be monitored throughout the study.

Conditions: Pulmonary Fungal Infection
Being tested: Itraconazole
Keywords: Invasive Pulmonary Fungal Infection, Itraconazole
Medical subject headings: Lung Diseases, Fungal

What participants receive

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

ItraconazoleDrug
Itraconazole 200 milligram (mg) intravenous injection will be given twice daily for first 2 days, 200 mg once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily will be given for 2 to 4 weeks.

Study groups in NCT01823289
Study group	Role	What they receive
Itraconazole Sequential Therapy	Experimental	Not described Receives: Drug: Itraconazole

What is being measured

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

Number of Participants With Clinical Efficacy
Clinical efficacy was assessed as cured: the signs and symptoms of invasive fungal infections (IFI) completely disappeared or full or nearby resolution of radiographic manifestations; markedly improved: the signs and symptoms of IFI were improved or disappeared and at least 50 percent improvement of radiographic findings; improved: the signs and symptoms of IFI were moderately improved and less than 50 percent improvement of radiographic findings; failed: the clinical symptoms and signs of IFI were not changed or worsened.
Measured: Week 6
Number of Participants With Mycological Efficacy
Mycological efficacy was assessed as fungi cleared: negative for fungal microscopic examination and culture (test for infection or organisms that could cause infection); fungi not cleared: positive for fungal microscopic examinations and/or culture.
Measured: Week 6
Number of Participants With Comprehensive Efficacy
Comprehensive efficacy was assessed as cured: the symptoms, signs, laboratory examination and pathogenic examination were return to normal; markedly improved: the disease condition was markedly improved but symptoms, signs, laboratory examination and pathogenic examination were not return to normal; improved: the disease condition was improved to some extent after drug administration, but the improvement was not significant enough; failed: the disease condition was not improved significantly or worsened after drug administration.
Measured: Week 6

Timeline

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

Jun 2007Jan 2009

First posted4 Apr 2013 (estimated)
Study startJun 2007
Primary completionDec 2008
Study completionJan 2009

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 Fungal InfectionStudies 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01823289
Sponsor's protocol ID: CR014362
Other IDs: ITRFUN4025, SPOIV-CHN-MA-04
Status last verified: Apr 2013
First submitted: 12 Mar 2013
Last updated: 31 May 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

Official record

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All Pulmonary Fungal Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Efficacy and Safety of Itraconazole Injection/Oral Solution Sequential Therapy for Treatment of Invasive Pulmonary Fungal Infections
ClinicalTrials.gov ID: NCT01823289
Acronym / sponsor ID: CR014362
Conditions: Pulmonary Fungal Infection
Keywords: Invasive Pulmonary Fungal Infection, Itraconazole
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 71 participants (actual)
Lead sponsor: Xian-Janssen Pharmaceutical Ltd.Industry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: Dec 2008 (actual)
Study completion: Jan 2009 (actual)
First posted: 4 Apr 2013 (estimated)
Results: Posted 31 May 2013

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Itraconazole Sequential Therapy	Experimental	Drug: Itraconazole

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Probable or proven invasive pulmonary infectious participants (IPFI) - Hospitalized participants (at least hospitalized treatment and observation could be ensured during the intravenous injection period) - The participants (or legal representatives) have signed the informed consent forms.

Key exclusion criteria (1 listed)

Currently taking taboo drugs, such as terfenadine, astemizole, cisapride and HMG CoA reductase inhibitors (for example simvastatin, lovastatin, oral or intravenous midazolam or triazolam) - History of allergy or intolerance to imidazoles or pyrrole drugs (for example fluconazole, itraconazole, ketoconazole, miconazole, clotrimazole) - Pregnant and breast feeding women, or women of child bearing age not taking effective contraception measures - Participants with pure oral, urinary tract, and vaginal candidiasis (yeast infection) - Participants with fungal meningitis (inflammation of the meninges), active liver disease, renal insufficiency with the serum creatinine clearance rate less than 30 milliliter per minute (ml/min), and current abnormal cardiac function such as congestive heart failure (condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body), or participants with history of congestive heart failure

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
ItraconazoleItraconazole 200 milligram (mg) intravenous injection will be given twice daily for first 2 days, 200 mg once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily will be given for 2 to 4 weeks.	Drug	Itraconazole Sequential Therapy

Primary outcome

Number of Participants With Clinical Efficacy
Time frame: Week 6
Clinical efficacy was assessed as cured: the signs and symptoms of invasive fungal infections (IFI) completely disappeared or full or nearby resolution of radiographic manifestations; markedly improved: the signs and symptoms of IFI were improved or disappeared and at least 50 percent improvement of radiographic findings; improved: the signs and symptoms of IFI were moderately improved and less than 50 percent improvement of radiographic findings; failed: the clinical symptoms and signs of IFI were not changed or worsened.
Number of Participants With Mycological Efficacy
Time frame: Week 6
Mycological efficacy was assessed as fungi cleared: negative for fungal microscopic examination and culture (test for infection or organisms that could cause infection); fungi not cleared: positive for fungal microscopic examinations and/or culture.
Number of Participants With Comprehensive Efficacy
Time frame: Week 6
Comprehensive efficacy was assessed as cured: the symptoms, signs, laboratory examination and pathogenic examination were return to normal; markedly improved: the disease condition was markedly improved but symptoms, signs, laboratory examination and pathogenic examination were not return to normal; improved: the disease condition was improved to some extent after drug administration, but the improvement was not significant enough; failed: the disease condition was not improved significantly or worsened after drug administration.

Results and safety

Results posted to the registry on 31 May 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Itraconazole Sequential Therapy	71	47

Primary outcome: Number of Participants With Clinical Efficacy

Time frame: Week 6. Number. Unit: participants

Measure	Itraconazole Sequential Therapy n = 60
Cured	8
Markedly Improved	29
Improved	18
Failed	5

Population analysed: The Full analysis set (FAS) population included all participants who received at least 1 intravenous infusion or oral solution of the study drug and completed at least 1 post-baseline visit.

Primary outcome: Number of Participants With Mycological Efficacy

Time frame: Week 6. Number. Unit: participants

Measure	Itraconazole Sequential Therapy n = 30
Fungi cleared	20
Fungi not cleared	10

Primary outcome: Number of Participants With Comprehensive Efficacy

Time frame: Week 6. Number. Unit: participants

Measure	Itraconazole Sequential Therapy n = 60
Cured	8
Markedly Improved	32
Improved	16
Failed	4

Adverse events

Time frame: From the signing of informed consent until end of the study (week 6).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Itraconazole Sequential Therapy	4 of 61 (6.6%)	13 of 61 (21.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Not yet recruitingPhase 3
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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.

Xian-Janssen Pharmaceutical Ltd., China Clinical trial study director

Xian-Janssen Pharmaceutical Ltd.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Itraconazole in people with Pulmonary Fungal Infection, run by Xian-Janssen Pharmaceutical Ltd..

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 1 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 31 May 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 31 May 2013). 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?

Number of Participants With Clinical Efficacy (time frame: Week 6). The study lists 3 primary outcomes in all. 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 NCT01823289.

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 31 May 2013.