UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037464 |
|---|---|
| Receipt number | 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 16:30:47 |
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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
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
isaoito@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Ono Municipal Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042262
| Research Plan | |
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| Registered date | File name |
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