- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT04764058
Efficacy and Safety of Colistin Based Antibiotic Therapy
Efficacy and Safety of Colistin Based Antibiotic Therapy for Multidrug Resistant Gram Negative Infections in Pediatric Intensive Care Unit
To evaluate the efficacy and safety of antibiotic combinations containing Colistin in the treatment of children with multidrug-resistant gram negative infections admitted in the pediatric surgery intensive care unit.
The main outcome measure is clinical and microbiological responses to therapy.
The secondary outcome is the occurrence of adverse events during Colistin combination treatment.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Patients and Methods
Design of the study:
- Prospective, Randomized, interventional study.
Setting:
- The study will be conducted in the pediatric surgery intensive care unit in Children's Hospitals, Ain Shams University, Cairo, Egypt.
Subjects:
- Pediatric patients admitted in pediatric surgery intensive care unit.
Inclusion criteria:
All children with culture-proven nosocomial infections due to multidrug resistance gram-negative organisms
Exclusion criteria:
- Patients who started on Colistin treatment outside the pediatric surgery intensive care unit and transferred to the unit afterward will be excluded.
- Patients who will receive <6 doses of intravenous Colistin will be excluded.
- Patients received Imipenem or Colistin-Imipenem compination as empirical antibiotic.
Methodology:
- Sixty pediatric patients admitted to the pediatric surgery intensive care unit will be enrolled in the study and will be randomly assigned to either Group I or Group II
Group I: Thirty patients will receive IV Colistin in dosages of 50,000-75,000 IU/kg/day in three divided doses, infused IV in 10mL normal saline over 30 minutes with IV Imipenem in doses of 15 to 25 mg/kg every 6 hours¬.21,22,24 Colistin formulation consists of 2 million IU per vial. Group II: Thirty patients will receive IV Imipenem in doses of 15 to 25 mg/kg every 6 hours¬. 22,24
For all patients the following data will be collected:
- Demographic data (age, gender, weight).
- The risk factors for nosocomial infections.
- Pediatric surgery intensive care unit stay.
- Type of surgeries performed.
- Site of isolation of organisms.
- The dose and duration of therapy.
- Serum creatinine levels will be assessed at baseline, once weekly and at the end of Colistin combination therapy.
- Nephrotoxic co-medication monitoring.
- Clinical (resolution of signs and symptoms of infection) and
- microbiological (bacteriologic responses) outcomes will be evaluated during treatment and at the end of the treatment.
According to the inclusion and exclusion criteria, the demographic data for the intended ICU patients was collected, then the sample was withdrawn from the infected site to be cultured on specific culture media (such as blood agar, MacConkey agar, Chocolate agar), and identification of the isolated microorganism was detected by biochemical tests and Vitek-2 compact system whenever required. Antimicrobial sensitivity to Colistin was tested using the micro broth dilution method, in order to be evaluated in Colistin therapy. After culture-proven, the drug was given, either IV Colistin-Imipenem/Cilastatin as a combination or Imipenem/Cilastatin as a monotherapy. Throughout this step, the hemodynamic parameters were measured during the process of treatment, without neglecting the serum creatinine level to detect any nephrotoxicity.
We assure the right drug handling, dosing, dispensing, and monitoring. At the end of the treatment, the duration and length of PICU stay were recorded.
The decision and/or conclusion of treatment failure and/ or success was based upon the worsening and/or improvement of the patients' parameters and their situation including the results of the microbiological examination before and after the intervention
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
- Fase 1
Contacten en locaties
Studie Locaties
-
-
-
Cairo, Egypte
- Ain Shams Univesity Hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- All children with culture proven nosocomial infections due to multidrug resistance gram-negative organisms
Exclusion Criteria:
1. Patients who started on Colistin treatment outside the pediatric surgery intensive care unit and transferred to the unit afterward will be excluded.
2. Patients who will receive <6 doses of intravenous Colistin will be excluded.
3. Patients received Imipenem or Colistin-Imipenem compination as empirical antibiotic.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Ander: Montherapy
Thirty patients will receive IV Imipenem in doses of 15 to 25 mg/kg every 6 hours
|
Imipenem and cilastatin sodium
Andere namen:
Health caregivers give the drug to the patients and monitoring the infusion rate
|
Ander: Combination
Thirty patients will receive IV Colistin in dosages of 50,000-75,000 IU/kg/day in three divided doses, infused IV in 10mL normal saline over 30 minutes with IV Imipenem in doses of 15 to 25 mg/kg every 6 hours¬.21,22,24
Colistin formulation consists of 2 million IU per vial.
|
Imipenem and cilastatin sodium
Andere namen:
Health caregivers give the drug to the patients and monitoring the infusion rate
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Hemodynamic Parameters Measurement ,heart beating rate.
Tijdsspanne: 2 year
|
the efficacy and safety of antibiotic combination containing Colistin.
We will monitor the heart beating rate.
|
2 year
|
Hemodynamic Parameters Measurement ,body temperature
Tijdsspanne: 2 year
|
the efficacy and safety of antibiotic combination containing Colistin.
We will monitor the body temperature
|
2 year
|
Hemodynamic Parameters Measurement ,respiratory rate.
Tijdsspanne: 2 year
|
the efficacy and safety of antibiotic combination containing Colistin.
We will monitor the respiratory rate.
|
2 year
|
Hemodynamic Parameters Measurement ,blood pressure
Tijdsspanne: 2 year
|
the efficacy and safety of antibiotic combination containing Colistin.
We will monitor the blood pressure
|
2 year
|
Hemodynamic Parameters Measurement ,partial oxygen saturation pressure
Tijdsspanne: 2 year
|
the efficacy and safety of antibiotic combination containing Colistin.
We will monitor the partial oxygen saturation pressure
|
2 year
|
Hemodynamic Parameters Measurement and Septic Markers, serum lactate
Tijdsspanne: 2 year
|
the efficacy and safety of antibiotic combination containing Colistin.
We will monitor the serum lactate
|
2 year
|
Hemodynamic Parameters Measurement ,serum creatinine
Tijdsspanne: 2 year
|
the efficacy and safety of antibiotic combination containing Colistin.
We will monitor the serum creatinine
|
2 year
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: AHMED S ATTIA, Heliopolis University
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Systemisch ontstekingsreactiesyndroom
- Ontsteking
- Bacteriële infecties en mycosen
- Sepsis
- Infecties
- Bacteriële infecties
- Moleculaire mechanismen van farmacologische werking
- Anti-infectieuze middelen
- Enzymremmers
- Proteaseremmers
- Antibacteriële middelen
- Cilastatine, Imipenem Geneesmiddelencombinatie
Andere studie-ID-nummers
- 210
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Tienam 500
-
Prince of Songkla UniversityMerck Sharp & Dohme LLCVoltooidVentilator-geassocieerde longontstekingThailand
-
Prince of Songkla UniversityMerck Sharp & Dohme LLCVoltooidPatiënten met febriele neutropenieThailand
-
SonaCare MedicalIngetrokken
-
SonaCare MedicalOnbekend
-
NestléBeëindigd
-
Mahidol UniversityOnbekendGeneesmiddelenveiligheidThailand
-
University Hospital, Strasbourg, FranceVoltooidTissulaire laesieFrankrijk
-
SonaCare MedicalOnbekendProstaatkankerVerenigde Staten
-
Günther HofbauerBeëindigdActinische keratoseZwitserland
-
Carmel Medical CenterVoltooidTekenen en symptomen, ademhaling | Allergie | Bronchiale astmaIsraël