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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
- Fase 1
Contactos e Locais
Locais de estudo
-
-
-
Cairo, Egito
- Ain Shams Univesity Hospital
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Outro: Montherapy
Thirty patients will receive IV Imipenem in doses of 15 to 25 mg/kg every 6 hours
|
Imipenem and cilastatin sodium
Outros nomes:
Health caregivers give the drug to the patients and monitoring the infusion rate
|
Outro: 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
Outros nomes:
Health caregivers give the drug to the patients and monitoring the infusion rate
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Hemodynamic Parameters Measurement ,heart beating rate.
Prazo: 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
Prazo: 2 year
|
the efficacy and safety of antibiotic combination containing Colistin.
We will monitor the body temperature
|
2 year
|
Hemodynamic Parameters Measurement ,respiratory rate.
Prazo: 2 year
|
the efficacy and safety of antibiotic combination containing Colistin.
We will monitor the respiratory rate.
|
2 year
|
Hemodynamic Parameters Measurement ,blood pressure
Prazo: 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
Prazo: 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
Prazo: 2 year
|
the efficacy and safety of antibiotic combination containing Colistin.
We will monitor the serum lactate
|
2 year
|
Hemodynamic Parameters Measurement ,serum creatinine
Prazo: 2 year
|
the efficacy and safety of antibiotic combination containing Colistin.
We will monitor the serum creatinine
|
2 year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: AHMED S ATTIA, Heliopolis University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Processos Patológicos
- Síndrome da Resposta Inflamatória Sistêmica
- Inflamação
- Infecções Bacterianas e Micoses
- Sepse
- Infecções
- Infecções bacterianas
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Anti-Infecciosos
- Inibidores Enzimáticos
- Inibidores de Protease
- Agentes antibacterianos
- Cilastatina, Combinação de Medicamentos Imipenem
Outros números de identificação do estudo
- 210
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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