Treatment of Blood Stream Infections Due to Multidrug-Resistant Klebsiella Pneumoniae Clinical Trial
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
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
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | July 2020 |
| Est. primary completion date | July 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Qasr El Ainy | Cairo |
| Lead Sponsor | Collaborator |
|---|---|
| Al-Azhar University |
Egypt,
Daikos GL, Petrikkos P, Psichogiou M, Kosmidis C, Vryonis E, Skoutelis A, Georgousi K, Tzouvelekis LS, Tassios PT, Bamia C, Petrikkos G. Prospective observational study of the impact of VIM-1 metallo-beta-lactamase on the outcome of patients with Klebsiella pneumoniae bloodstream infections. Antimicrob Agents Chemother. 2009 May;53(5):1868-73. doi: 10.1128/AAC.00782-08. Epub 2009 Feb 17. — View Citation
Maltezou HC, Giakkoupi P, Maragos A, Bolikas M, Raftopoulos V, Papahatzaki H, Vrouhos G, Liakou V, Vatopoulos AC. Outbreak of infections due to KPC-2-producing Klebsiella pneumoniae in a hospital in Crete (Greece). J Infect. 2009 Mar;58(3):213-9. doi: 10.1016/j.jinf.2009.01.010. Epub 2009 Feb 26. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 7-14 days | ||
| Secondary | 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 | 7-14 days |