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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037464
Receipt No. R000042262
Scientific Title Open-label randomized comparative study of ceftriaxone vs. ampicillin/sulbactam in adults with mild to moderate community-acquired pneumonia
Date of disclosure of the study information 2019/07/25
Last modified on 2019/11/25

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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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