Trial Outcomes & Findings for An Efficacy and Safety Study of Itraconazole Sequential Therapy (Intravenous Injection Followed by Oral Solution) in Invasive Pulmonary Fungal Infections (NCT NCT01823289)

Last Updated: 2013-05-31

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

71 participants

Primary outcome timeframe

Week 6

Results posted on

2013-05-31

Participant Flow

Participant milestones

Participant milestones
Measure	Itraconazole Sequential Therapy Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
Overall Study STARTED	71
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Itraconazole Sequential Therapy Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
Overall Study Lost to Follow-up	5
Overall Study Adverse Event	5
Overall Study Lack of Efficacy	1
Overall Study Physician Decision	9
Overall Study Administered contraindicated medicine	1
Overall Study Transaminase increased more than 3 times	1
Overall Study Drug affected efficacy and safety	1
Overall Study Creatinine clearance<30milliliter/minute	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Itraconazole Sequential Therapy n=60 Participants Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
Age Continuous	55.5 years n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 6

Population: 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.

Outcome measures

Outcome measures
Measure	Itraconazole Sequential Therapy n=60 Participants Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
Number of Participants With Clinical Efficacy Cured	8 participants
Number of Participants With Clinical Efficacy Markedly Improved	29 participants
Number of Participants With Clinical Efficacy Improved	18 participants
Number of Participants With Clinical Efficacy Failed	5 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Itraconazole Sequential Therapy n=30 Participants Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
Number of Participants With Mycological Efficacy Fungi cleared	20 participants
Number of Participants With Mycological Efficacy Fungi not cleared	10 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Itraconazole Sequential Therapy n=60 Participants Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
Number of Participants With Comprehensive Efficacy Cured	8 participants
Number of Participants With Comprehensive Efficacy Markedly Improved	32 participants
Number of Participants With Comprehensive Efficacy Improved	16 participants
Number of Participants With Comprehensive Efficacy Failed	4 participants

Adverse Events

Itraconazole Sequential Therapy

Serious events: 4 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Itraconazole Sequential Therapy n=61 participants at risk Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
General disorders Edema	1.6% 1/61 • From the signing of informed consent until end of the study (week 6). Safety set (SS) population (N=61) included all participants who received at least 1 dose of study drug and had safety documents.
General disorders Death	3.3% 2/61 • From the signing of informed consent until end of the study (week 6). Safety set (SS) population (N=61) included all participants who received at least 1 dose of study drug and had safety documents.
Immune system disorders Fungal infection	1.6% 1/61 • From the signing of informed consent until end of the study (week 6). Safety set (SS) population (N=61) included all participants who received at least 1 dose of study drug and had safety documents.
Respiratory, thoracic and mediastinal disorders Hemoptysis	1.6% 1/61 • From the signing of informed consent until end of the study (week 6). Safety set (SS) population (N=61) included all participants who received at least 1 dose of study drug and had safety documents.

Other adverse events

Other adverse events
Measure	Itraconazole Sequential Therapy n=61 participants at risk Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
Blood and lymphatic system disorders Granulocytopenia	1.6% 1/61 • From the signing of informed consent until end of the study (week 6). Safety set (SS) population (N=61) included all participants who received at least 1 dose of study drug and had safety documents.
Metabolism and nutrition disorders Hypokalaemia	4.9% 3/61 • From the signing of informed consent until end of the study (week 6). Safety set (SS) population (N=61) included all participants who received at least 1 dose of study drug and had safety documents.
Hepatobiliary disorders Hyperbilirubinemia	1.6% 1/61 • From the signing of informed consent until end of the study (week 6). Safety set (SS) population (N=61) included all participants who received at least 1 dose of study drug and had safety documents.
Hepatobiliary disorders Hepatic function abnormal	4.9% 3/61 • From the signing of informed consent until end of the study (week 6). Safety set (SS) population (N=61) included all participants who received at least 1 dose of study drug and had safety documents.
Hepatobiliary disorders GPT increased	1.6% 1/61 • From the signing of informed consent until end of the study (week 6). Safety set (SS) population (N=61) included all participants who received at least 1 dose of study drug and had safety documents.
Renal and urinary disorders Urinary tract infection	1.6% 1/61 • From the signing of informed consent until end of the study (week 6). Safety set (SS) population (N=61) included all participants who received at least 1 dose of study drug and had safety documents.
Renal and urinary disorders Renal function abnormal	1.6% 1/61 • From the signing of informed consent until end of the study (week 6). Safety set (SS) population (N=61) included all participants who received at least 1 dose of study drug and had safety documents.
Skin and subcutaneous tissue disorders Dermatoses	1.6% 1/61 • From the signing of informed consent until end of the study (week 6). Safety set (SS) population (N=61) included all participants who received at least 1 dose of study drug and had safety documents.
Skin and subcutaneous tissue disorders Rash	1.6% 1/61 • From the signing of informed consent until end of the study (week 6). Safety set (SS) population (N=61) included all participants who received at least 1 dose of study drug and had safety documents.
General disorders Night sweating	1.6% 1/61 • From the signing of informed consent until end of the study (week 6). Safety set (SS) population (N=61) included all participants who received at least 1 dose of study drug and had safety documents.
General disorders Fever	1.6% 1/61 • From the signing of informed consent until end of the study (week 6). Safety set (SS) population (N=61) included all participants who received at least 1 dose of study drug and had safety documents.
General disorders Abdominal pain	1.6% 1/61 • From the signing of informed consent until end of the study (week 6). Safety set (SS) population (N=61) included all participants who received at least 1 dose of study drug and had safety documents.
General disorders Septic shock	1.6% 1/61 • From the signing of informed consent until end of the study (week 6). Safety set (SS) population (N=61) included all participants who received at least 1 dose of study drug and had safety documents.
General disorders Headache	1.6% 1/61 • From the signing of informed consent until end of the study (week 6). Safety set (SS) population (N=61) included all participants who received at least 1 dose of study drug and had safety documents.
Gastrointestinal disorders Nausea	3.3% 2/61 • From the signing of informed consent until end of the study (week 6). Safety set (SS) population (N=61) included all participants who received at least 1 dose of study drug and had safety documents.
Gastrointestinal disorders Non-specific anorexia	1.6% 1/61 • From the signing of informed consent until end of the study (week 6). Safety set (SS) population (N=61) included all participants who received at least 1 dose of study drug and had safety documents.
Gastrointestinal disorders Diarrhea	3.3% 2/61 • From the signing of informed consent until end of the study (week 6). Safety set (SS) population (N=61) included all participants who received at least 1 dose of study drug and had safety documents.
Gastrointestinal disorders Vomiting	1.6% 1/61 • From the signing of informed consent until end of the study (week 6). Safety set (SS) population (N=61) included all participants who received at least 1 dose of study drug and had safety documents.
Cardiac disorders Palpitation	1.6% 1/61 • From the signing of informed consent until end of the study (week 6). Safety set (SS) population (N=61) included all participants who received at least 1 dose of study drug and had safety documents.
Nervous system disorders Dizziness	1.6% 1/61 • From the signing of informed consent until end of the study (week 6). Safety set (SS) population (N=61) included all participants who received at least 1 dose of study drug and had safety documents.
Nervous system disorders Tremor	1.6% 1/61 • From the signing of informed consent until end of the study (week 6). Safety set (SS) population (N=61) included all participants who received at least 1 dose of study drug and had safety documents.
Respiratory, thoracic and mediastinal disorders Hemoptysis	1.6% 1/61 • From the signing of informed consent until end of the study (week 6). Safety set (SS) population (N=61) included all participants who received at least 1 dose of study drug and had safety documents.

Additional Information

Director of Respiratory Department

Department of Respiratory Medicine, SHANGHAI First People's Hospital Affiliated to SHANGHAI JiaoTong University

Phone: 86-21-63071428

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60