- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
- Fas 1
Kontakter och platser
Studieorter
-
-
-
Cairo, Egypten
- Ain Shams Univesity Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Övrig: Montherapy
Thirty patients will receive IV Imipenem in doses of 15 to 25 mg/kg every 6 hours
|
Imipenem and cilastatin sodium
Andra namn:
Health caregivers give the drug to the patients and monitoring the infusion rate
|
Övrig: 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
Andra namn:
Health caregivers give the drug to the patients and monitoring the infusion rate
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Hemodynamic Parameters Measurement ,heart beating rate.
Tidsram: 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
Tidsram: 2 year
|
the efficacy and safety of antibiotic combination containing Colistin.
We will monitor the body temperature
|
2 year
|
Hemodynamic Parameters Measurement ,respiratory rate.
Tidsram: 2 year
|
the efficacy and safety of antibiotic combination containing Colistin.
We will monitor the respiratory rate.
|
2 year
|
Hemodynamic Parameters Measurement ,blood pressure
Tidsram: 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
Tidsram: 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
Tidsram: 2 year
|
the efficacy and safety of antibiotic combination containing Colistin.
We will monitor the serum lactate
|
2 year
|
Hemodynamic Parameters Measurement ,serum creatinine
Tidsram: 2 year
|
the efficacy and safety of antibiotic combination containing Colistin.
We will monitor the serum creatinine
|
2 year
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: AHMED S ATTIA, Heliopolis University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Systemiskt inflammatoriskt svarssyndrom
- Inflammation
- Bakteriella infektioner och mykoser
- Sepsis
- Infektioner
- Bakteriella infektioner
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Enzyminhibitorer
- Proteashämmare
- Antibakteriella medel
- Cilastatin, Imipenem Läkemedelskombination
Andra studie-ID-nummer
- 210
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Bakteriella infektioner
-
Institut PasteurRekrytering
-
Duke UniversityAvslutadCentral Line-associated Bloodstream Infection (CLABSI)Förenta staterna
-
Catholic University of the Sacred HeartAvslutadCentral Line-associated Bloodstream Infection (CLABSI)
-
Forest LaboratoriesIndragenCommunity-acquired Bacterial Pneumonia (CABP)
-
The University of Texas Health Science Center,...EurofinsAvslutadOdontogen Deep Space Neck InfectionFörenta staterna
-
Princess Maxima Center for Pediatric OncologyUMC Utrecht; Dutch Cancer SocietyRekryteringCentral Line-associated Bloodstream Infection (CLABSI)Nederländerna
-
WockhardtACMAvslutadCommunity-acquired Bacterial Pneumonia (CABP)Förenta staterna
-
Furiex Pharmaceuticals, IncAvslutadCommunity-acquired Bacterial Pneumonia (CABP)Förenta staterna, Kanada, Colombia, Tyskland, Ungern, Polen
-
University of MalayaTeleflexRekryteringCLABSI - Central Line Associated Bloodstream InfectionMalaysia
-
Johns Hopkins UniversityAvslutadCLABSI - Central Line Associated Bloodstream InfectionFörenta staterna
Kliniska prövningar på Tienam 500
-
Prince of Songkla UniversityMerck Sharp & Dohme LLCAvslutadVentilatorassocierad lunginflammationThailand
-
Prince of Songkla UniversityMerck Sharp & Dohme LLCAvslutadPatienter med febril neutropeniThailand
-
SonaCare MedicalIndragen
-
SonaCare MedicalOkänd
-
SonaCare MedicalOkändProstatacancerFörenta staterna
-
University Hospital, Strasbourg, FranceAvslutadVävnadsskadaFrankrike
-
NestléAvslutad
-
Günther HofbauerAvslutadAktinisk keratosSchweiz
-
Mahidol UniversityOkänd
-
Decathlon SEEFOR, FranceRekryteringEpikondylit | Armbågs stukningFrankrike