Comparative Clinical Study Between Colistin-Tigecycline Combined Therapy Versus Colistin-Meropenem Combined Therapy in Treatment of Blood Stream Infections With Multidrug-Resistant Klebsiella Pneumoniae
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| ClinicalTrials.gov Identifier: NCT04489459 |
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Recruitment Status :
Recruiting
First Posted : July 28, 2020
Last Update Posted : July 29, 2020
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This prospective, comparative study is evaluating the effectiveness and adverse effects of using colistin at a loading dose of 9 million international units (MIU) followed by 4.5 MIU every 12 h (q12 h) + tigecycline at a loading dose of 100 mg followed by 50 mg every 12 h (q12 h) versus colistin + meropenem 2 g q8 h in treating blood stream infections due to multidrug-resistant (MDR) Klebsiella pneumoniae. The aims of the current study are to investigate and evaluate the therapeutic activity and side effects of Colistin-Meropenem combined therapy versus Colistin-Tigecycline combined therapy in treatment of patients with Multiple Drug Resistant (MDR)-Klebsiella pneumonia bacteraemia The primary goal is comparing 14 day mortality between critically ill patients with MDR Gram-negative Klebsiella pneumoniae infection as evaluation of the therapeutic activity of colistin - tigecycline vs. colistin - meropenem combined therapies. The secondary goal is comparing the comorbidities (nephrotoxicity, hepatotoxicity, neurotoxicity, hematological changes) between critically ill patients with MDR Gram-negative Klebsiella pneumoniae infection who will be treated with colistin - tigecycline versus colistin - meropenem combined therapies.
Method: A total of 60 patients were divided into two groups (30 patients each); the first group received Intravenous colistin 9 MIU IV infusion over 2 hours loading dose followed by maintenance dose 4.5 MIU IV infusion over 2 hours q12 h plus Intravenous Tigecycline 100 mg IV infusion over 1 hour loading dose followed by maintenance dose 50 mg IV infusion over 1 hour q12 and the second group received Intravenous colistin 9 MIU IV infusion over 2 hours loading dose followed by maintenance dose 4.5 MIU IV infusion over 2 hours q12 h plus Intravenous meropenem 2 g IV infusion over 30 minutes q8 h
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Treatment of Blood Stream Infections Due to Multidrug-Resistant Klebsiella Pneumoniae | Drug: Colistin Drug: Meropenem Drug: Tigecycline | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Masking Description: | single-blind |
| Primary Purpose: | Treatment |
| Official Title: | Comparative Clinical Study Between Colistin-Tigecycline Combined Therapy Versus Colistin-Meropenem Combined Therapy in Treatment of Blood Stream Infections With Multidrug-Resistant Klebsiella Pneumoniae |
| Actual Study Start Date : | September 21, 2019 |
| Estimated Primary Completion Date : | July 2020 |
| Estimated Study Completion Date : | July 2020 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: colistin-tigecycline
this group received Intravenous colistin 9 MIU IV infusion over 2 hours loading dose followed by maintenance dose 4.5 MIU IV infusion over 2 hours q12 h plus Intravenous Tigecycline 100 mg IV infusion over 1 hour loading dose followed by maintenance dose 50 mg IV infusion over 1 hour q12h
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Drug: Colistin
Intravenous colistin 9 MIU IV infusion over 2 hours loading dose followed by maintenance dose 4.5 MIU IV infusion over 2 hours q12 h
Other Name: polymixin B Drug: Tigecycline Intravenous Tigecycline 100 mg IV infusion over 1 hour loading dose followed by maintenance dose 50 mg IV infusion over 1 hour q12 |
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Active Comparator: colistin-meropenem
received Intravenous colistin 9 MIU IV infusion over 2 hours loading dose followed by maintenance dose 4.5 MIU IV infusion over 2 hours q12 h plus Intravenous meropenem 2 g IV infusion over 30 minutes q8 h
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Drug: Colistin
Intravenous colistin 9 MIU IV infusion over 2 hours loading dose followed by maintenance dose 4.5 MIU IV infusion over 2 hours q12 h
Other Name: polymixin B Drug: Meropenem Intravenous meropenem 2 g IV infusion over 30 minutes q8 h |
- Comparing 14 day mortality between critically ill patients with MDR Gram-negative Klebsiella pneumoniae infection as evaluation of the therapeutic activity of colistin - tigecycline vs. colistin - meropenem combined therapies. [ Time Frame: 7-14 days ]
- Comparing comorbidities:nephrotoxicity,hepatotoxicity,neurotoxicity,hematological changes between critically ill patients with MDR Gram-negative Klebsiella pneumoniae infection treated with colistin-tigecycline vs colistin-meropenem [ Time Frame: 7-14 days ]
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| Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Patients with blood stream infection caused by MDR K. pneumoniae, as defined by Infectious Diseases Society of America (IDSA), who were hospitalised in the general ICU, confirmed with carbapenem-resistant K. pneumoniae-positive culture results from blood sample within the previous 5 days
Exclusion Criteria:
- All patients without a MDR carbapenem-resistant K. pneumoniae-positive culture isolated from the blood. In addition, the following patients are excluded: patients with a Glasgow Coma Scale (GCS) score of <9 in non-ventilated patients or <6 in ventilated patients; patients with end-stage metastatic malignant cancer; and all terminal patients with Acute Physiology and Chronic Health Evaluation (APACHE) II or Sequential Organ Failure Assessment (SOFA) scores of >34 or >15, respectively, and risk of mortality >85% or >80% on the first day of colistin administration, respectively [27,28]. Moreover, patients who received i.v. colistin combination therapies for <72 h are excluded from further analysis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04489459
| Contact: Salma Wagih Abdalla, Bachelor | 00201100701178 | salma9793@gmail.com |
| Egypt | |
| Qasr El Ainy | Recruiting |
| Cairo, Egypt | |
| Responsible Party: | Salma Wagih Abdalla, Principle Investigator, Al-Azhar University |
| ClinicalTrials.gov Identifier: | NCT04489459 |
| Other Study ID Numbers: |
D12019 |
| First Posted: | July 28, 2020 Key Record Dates |
| Last Update Posted: | July 29, 2020 |
| Last Verified: | July 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Colistin Tigecycline Meropenem |
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Infection Communicable Diseases Klebsiella Infections Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Enterobacteriaceae Infections Gram-Negative Bacterial Infections Bacterial Infections |
Meropenem Colistin Tigecycline Polymyxins Polymyxin B Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |