UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008561 |
|---|---|
| Receipt number | R000010063 |
| Scientific Title | Prospective controlled trial of piperacillin versus ampicillin for lower respiratory infection caused by Haemophilus influenzae |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2012/07/29 21:51:01 |
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Basic information
Public title
Prospective controlled trial of piperacillin versus ampicillin for lower respiratory infection caused by Haemophilus influenzae
Acronym
Controlled trial of PIPC vs ABPC for Hi Bronchitis/Pnerumonia
Scientific Title
Prospective controlled trial of piperacillin versus ampicillin for lower respiratory infection caused by Haemophilus influenzae
Scientific Title:Acronym
Controlled trial of PIPC vs ABPC for Hi Bronchitis/Pnerumonia
Region
| Japan |
Condition
Condition
Acute bronchitis/pneumoniae caused by Haemophilus influenzae
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical efficacy, adverse effect, and resistant bacteria frequency of appearance at the time of using PIPC as an initial antimicrobial therapy for lower respratory infection caused by Haemophilus influenzae as compared with the cases using ABPC.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Alleviation of fever.
Calming of respiratory tract condition.
Reduced frequency of antimicrobial resistant bacteriae(especially beta lactamase non-producing ampicillin resistant H.influenzae:BLNAR).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Piperacillin 100mg/kg divided to 3 times per day, intravenous.
Interventions/Control_2
Ampicillin 100mg/kg divided to 3 times per day, intravenous.
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
| 3 | months-old | <= |
Age-upper limit
| 180 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
The lower airway infection patient by whom the gram negative bacteria considered to be Haemophilus influenzae were detected at predominance by the Gram's stain of sputum.
Key exclusion criteria
The case considered that the medical treatment by a penicillin system antimicrobial drug independent is unsuitable since it is in critical states, such as acute respiratory failure and a septic shock
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | ABE Katsuaki |
Organization
Chiba Kaihin municipal hospital
Division name
Pediatrics
Zip code
Address
Isobe 3-31-1, Mihama ward, Chiba city, Chiba prefacture, Japan.
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | ABE Katsuaki |
Organization
Chiba Kaihin municipal hospital
Division name
Pediatrics
Zip code
Address
TEL
043-277-7711
Homepage URL
http://www.city.chiba.jp/byoin/kaihin/kaihintop.html
Sponsor or person
Institute
Chiba Kaihin municipal hospital
Institute
Department
Personal name
Funding Source
Organization
Chiba Kaihin municipal hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
千葉市立海浜病院(千葉県)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2012 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 29 | Day |
Last modified on
| 2012 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010063
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
