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UMIN-CTR Clinical Trial |
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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 |
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 | |
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Condition | |||
Condition | Community-acquired pneumonia | ||
Classification by specialty |
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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 |
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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. |
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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. |
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Interventions/Control_3 | ||
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Interventions/Control_8 | ||
Interventions/Control_9 | ||
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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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 |
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Target sample size | 120 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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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. | ||||||
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Recruitment status | Completed | ||||||
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Management information | |||||||
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Last modified on |
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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 |