Phase 4 N=71 Treatment

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

Pulmonary Fungal Infection

Bottom Line

View on ClinicalTrials.gov: NCT01823289 ↗

Enrolled (actual)

Serious AEs

6.6%

Results posted

May 2013

Primary outcome: Primary: Number of Participants With Clinical Efficacy — 8; 29; 18; 5 participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Itraconazole (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Xian-Janssen Pharmaceutical Ltd.
Primary completion: Dec 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Clinical Efficacy	8; 29; 18; 5	—
PRIMARY Number of Participants With Mycological Efficacy	20; 10	—
PRIMARY Number of Participants With Comprehensive Efficacy	8; 32; 16; 4	—

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).

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01823289). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.