UMIN-CTR Clinical Trial

Basic information
Public title	Open-label randomized comparative study of ceftriaxone vs. ampicillin/sulbactam in adults with mild to moderate community-acquired pneumonia
Acronym	Comparative study of ceftriaxone vs. ampicillin/sulbactam in adult community-acquired pneumonia
Scientific Title	Open-label randomized comparative study of ceftriaxone vs. ampicillin/sulbactam in adults with mild to moderate community-acquired pneumonia
Scientific Title:Acronym	Comparative study of ceftriaxone vs. ampicillin/sulbactam in adult community-acquired pneumonia
Region	Japan

Condition
Condition	Community-acquired pneumonia
Classification by specialty	Pneumology Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare clinical effectiveness between ceftriaxone and ampicillin/sulbactam in adult patients with mild to moderate community-acquired pneumonia.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Clinical response at the end of therapy, days 11-14
Key secondary outcomes	Early clinical response at days 4 and 7 Bacteriological response at days 11-14 (in bacteriologically evaluable patients) Survival at day 30

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Ceftriaxone 2g IV, every 24 hrs, for 4-14 days. Clarithromycin 200mg PO, bid, for 4-14 days. May be adjusted when renal failure.
Interventions/Control_2	Ampicillin/sulbactam 3g IV, every 12 hrs, for 4-14 days. Clarithromycin 200mg PO, bid, for 4-14 days. May be adjusted when renal failure.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	15 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Patients with community-acquired pneumonia aged 15 yrs or more (2) Radiological appearance of a new and/or progressive pulmonary infiltrate(s) (3) At least two of the followings: cough, sputum or change of sputum character (increased volume and/or purulence), dyspnea, tachypnea, abnormal breathing sound (wheeze etc.), pleuritic chest pain, auscultatory findings on chest examination consistent with the lung infiltrate, documented axillary body temperature > or = 37.5C within the past 24hrs, rigors and/or chills, general malaise, and a WBC count of > or = 10,000/mm3 or < 3,000/mm3.
Key exclusion criteria	(1) Hospital-acquired pneumonia (2) Hospitalization within 60 days prior to the development of the symptom(s) (3) Immunocompromising disease or receipt of immunopompromising therapy (4) Active lung cancer (5) Terminal illness (6) Pregnancy or breast-feeding (7) Known allergy to the indicated antibiotics (8) Other infiltrative diseases (e.g. radiation pneumonitis, organizing pneumonia, drug-induced pneumonia, obstructive pneumonia etc.) (9) Tuberculosis, fungal infection (10) Empyema (11) Aspiration pneumonia
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Isao Middle name Last name Ito
Organization	Kyoto University
Division name	Department of Respiratory Medicine
Zip code	606-8507
Address	54 Shogoin-kawaharacho, Sakyo, Kyoto, 606-8507, Japan
TEL	075-751-3884
Email	isaoito@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Isao Middle name Last name Ito
Organization	Kyoto University Hospital
Division name	Department of Respiratory Medicine
Zip code	606-8507
Address	54 Shogoin-kawaharacho, Sakyo, Kyoto, 606-8507, Japan
TEL	075-751-3884
Homepage URL
Email	isaoito@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Ono Municipal Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee of Ono Municipal Hospital
Address	323 Nakamachi, Ono-city, 675-1332, Japan
Tel	0794-63-2020
Email	isaoito@kuhp.kyoto-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 07 Month 25 Day

Related information
URL releasing protocol	nothing
Publication of results	Unpublished

Result
URL related to results and publications	nothing
Number of participants that the trial has enrolled	230
Results	There was no significant difference in clinical response between ABPC/SBT and CTRX in CAP patients without risk factors for aspiration at EOT. But ABPC/SBT was more effective than CTRX at day 7.
Results date posted	2019 Year 07 Month 24 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	CAP patients without risk factor for aspiration
Participant flow	CAP patients who had been hospitalized from June 2002 to June 2008 were included. Patients were randomized to receive CTRX or ABPC/SBT intravenously.
Adverse events	Adverse events were observed in 18 patients (20 events) in the CTRX group and 16 patients (16 events) in the ABPC/SBT group. Diarrhea was most frequently observed in both groups.
Outcome measures	There was no significant difference in clinical response between ABPC/SBT and CTRX in CAP patients without risk factors for aspiration at EOT. But ABPC/SBT was more effective than CTRX at day 7.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2002 Year 03 Month 15 Day
Date of IRB	2002 Year 05 Month 31 Day
Anticipated trial start date	2002 Year 06 Month 03 Day
Last follow-up date	2008 Year 07 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 07 Month 24 Day
Last modified on	2019 Year 11 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042262

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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