Antibiotic Resistant InfectionEarly Phase 1NCT03950544
The Combined Antibiotic Therapy for Carbapenem Resistant Klebsiella Pneumoniae
A Early Phase 1 study testing Fosfomycin, Tigecycline and Polymyxin B in people with Antibiotic Resistant Infection, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
The infection of carbapenem resistant klebsiella pneumoniae (CRKP) is increasingly serious.Based on the early experimental basis and relevant research background,this study intends to separate and purify the CRKP from the bronchoalveolar lavage fluid (BALF) of the clinical patients.Designed by checkerboard assay and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Antibiotic Resistant Infection
- What is being tested?
- Fosfomycin, Tigecycline and Polymyxin B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age from 18 to 90.
- infected with CRKP firstly .
Who cannot join
- APACHE II score > 35
- Vital signs are unstable
- Unable to tolerate fiberoptic bronchoscopy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai 10th people's hospital
Shanghai, Shanghai Municipality, 201300
Huanlong Qin, director, 18917683138, wangsheng@tongji.edu.cn
About this study
Official title: How to Optimize the Combined Antibiotic Therapy for Carbapenem Resistant Klebsiella Pneumoniae
The infection of carbapenem resistant klebsiella pneumoniae (CRKP) is increasingly serious.Based on the early experimental basis and relevant research background,this study intends to separate and purify the CRKP from the bronchoalveolar lavage fluid (BALF) of the clinical patients.Designed by checkerboard assay and time-kill assay(TKA)，this study can explore the best combination therapy based on carbapenems.
Read the detailed description
- Collect the BALF from patients diagnosed with CRKP infection in surgical intensive care unit（SICU）of Shanghai 10th people's hospital.
- Separate and purify the BALF. Divide each CRKP into four treatment groups based on meropenem.
3.1 By checkerboard method and microdilution broth method,get the minimal inhibitory concentration (MICS) of two antibiotics,then calculate the fractional inhibitory concentration (FIC) index according to MIC results.
3.2 Observe the effect of two antibiotics on the growth of CRKP by TKA.
4.By the above two invitro experiments, analyze the data of the experimental results and get the best combination therapy based on carbapenems.
- Conditions
- Antibiotic Resistant Infection
- Being tested
- Fosfomycin, Tigecycline, Polymyxin B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FosfomycinDrug
Also called meropenem
Fosfomycin and meropenem
TigecyclineDrug
Also called meropenem
Tigecycline and meropenem
Polymyxin BDrug
Also called meropenem
Polymyxin B and meropenem
| Study group | Role | What they receive |
|---|---|---|
| only meropenem therapy, | Experimental | this group is only meropenem therapy as a single antibiotic treatment Receives: Drug: Fosfomycin; Drug: Tigecycline; Drug: Polymyxin B |
What is being measured
The primary outcome is the main question the study is designed to answer.
the fractional inhibitory concentration index (FICI)
By checkerboard method and microdilution broth method,get the minimal inhibitory concentration (MICS) of two antibiotics,then calculate the fractional inhibitory concentration (FIC) index according to MIC results.
Evaluation index:
FIC=0.5 , coordinating effect. 0.5 < FIC <1, adding effect;
1 < FIC <2, irrelevant.
Measured: 24hours-36hours
Secondary outcomes (1)
the time-kill assay (TKA)
According to the Clinical and Laboratory Standards Institute,observe the changes of bacterial growth over time after different combination therapy.
Measured: 36hours-48hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start1 Jan 2019
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antibiotic Resistant InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng Wang MD PhD, Shanghai 10th People's Hospital
- Investigators
- Li Hua, master, Principal investigator, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950544
- Sponsor's protocol ID
- STPH-ICU-002
- Status last verified
- Apr 2019
- First submitted
- 30 Oct 2018
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Du Y, Mu S, Liu Y, Yuan Y, Zhu Y, Ma L, Wang Q, Zhu Z, Liu Y, Wang S. The Genomic Characterization of KPC-Producing Klebsiella pneumoniae from the ICU of a Teaching Hospital in Shanghai, China. Infect Drug Resist. 2022 Jan 11;15:69-81. doi: 10.2147/IDR.S343673. eCollection 2022.
PubMed 35046672
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How to Optimize the Combined Antibiotic Therapy for Carbapenem Resistant Klebsiella Pneumoniae
- ClinicalTrials.gov ID
- NCT03950544
- Acronym / sponsor ID
- STPH-ICU-002
- Conditions
- Antibiotic Resistant Infection
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 15 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The infection of carbapenem resistant klebsiella pneumoniae (CRKP) is increasingly serious.Based on the early experimental basis and relevant research background,this study intends to separate and purify the CRKP from the bronchoalveolar lavage fluid (BALF) of the clinical patients.Designed by checkerboard assay and time-kill assay(TKA)，this study can explore the best combination therapy based on carbapenems.
Detailed description
- Collect the BALF from patients diagnosed with CRKP infection in surgical intensive care unit（SICU）of Shanghai 10th people's hospital.
- Separate and purify the BALF. Divide each CRKP into four treatment groups based on meropenem.
3.1 By checkerboard method and microdilution broth method,get the minimal inhibitory concentration (MICS) of two antibiotics,then calculate the fractional inhibitory concentration (FIC) index according to MIC results.
3.2 Observe the effect of two antibiotics on the growth of CRKP by TKA.
4.By the above two invitro experiments, analyze the data of the experimental results and get the best combination therapy based on carbapenems.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| only meropenem therapy, | Experimental | Drug: Fosfomycin, Drug: Tigecycline, Drug: Polymyxin Bthis group is only meropenem therapy as a single antibiotic treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age from 18 to 90.
- infected with CRKP firstly .
Key exclusion criteria (3 listed)
- APACHE II score > 35
- Vital signs are unstable
- Unable to tolerate fiberoptic bronchoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FosfomycinAlso: meropenemFosfomycin and meropenem | Drug | only meropenem therapy, |
| TigecyclineAlso: meropenemTigecycline and meropenem | Drug | only meropenem therapy, |
| Polymyxin BAlso: meropenemPolymyxin B and meropenem | Drug | only meropenem therapy, |
Primary outcome
the fractional inhibitory concentration index (FICI)
Time frame: 24hours-36hours
By checkerboard method and microdilution broth method,get the minimal inhibitory concentration (MICS) of two antibiotics,then calculate the fractional inhibitory concentration (FIC) index according to MIC results. Evaluation index: FIC=0.5 , coordinating effect. 0.5 < FIC <1, adding effect; 1 < FIC <2, irrelevant.
1 secondary outcome
the time-kill assay (TKA)
Time frame: 36hours-48hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Derived from this study: PubMed 35046672Du Y, Mu S, Liu Y, Yuan Y, Zhu Y, Ma L, Wang Q, Zhu Z, Liu Y, Wang S. The Genomic Characterization of KPC-Producing Klebsiella pneumoniae from the ICU of a Teaching Hospital in Shanghai, China. Infect Drug Resist. 2022 Jan 11;15:69-81. doi: 10.2147/IDR.S343673. eCollection 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Hua, master principal investigator
Shanghai 10th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fosfomycin, Tigecycline and Polymyxin B in people with Antibiotic Resistant Infection, run by Shanghai 10th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ma Lao, master (8613532437896, 13532437896@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the fractional inhibitory concentration index (FICI) (time frame: 24hours-36hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03950544, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019.