An Early Phase 1 interventional study of Fosfomycin and Tigecycline in Antibiotic Resistant Infection, sponsored by Shanghai 10th People's Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-05-15.
Sponsored by Shanghai 10th People's Hospital · Early Phase 1, Interventional, and Treatment
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.
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.
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's planned enrollment of 80 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Shanghai 10th People's Hospital is the lead sponsor of 167 studies on the registry; 45 are open to participants now.
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Exclusion Criteria:
this group is only meropenem therapy as a single antibiotic treatment
Drug: Fosfomycin · Drug: Tigecycline · Drug: Polymyxin B
Fosfomycin and meropenem
Also known as: meropenem
Tigecycline and meropenem
Also known as: meropenem
Polymyxin B and meropenem
Also known as: meropenem
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.
Time frame: 24hours-36hours
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.
Time frame: 36hours-48hours
Plan to share: No
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Shanghai 10th People's Hospital