SepticemiaPhase 1/2NCT04764058
Efficacy and Safety of Colistin Based Antibiotic Therapy
A Phase 1/2 study testing Tienam 500 and Infusion in people with Septicemia and Bacterial Infections, run by Ain Shams University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Septicemia, Bacterial Infections
- What is being tested?
- Tienam 500 and Infusion
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2017to 1 Sep 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All children with culture proven nosocomial infections due to multidrug resistance gram-negative organisms
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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
- Conditions
- Septicemia, Bacterial Infections
- Being tested
- Tienam 500, Infusion
- Medical subject headings
- Sepsis, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tienam 500Drug
Also called Meronem
Imipenem and cilastatin sodium
InfusionDevice
Health caregivers give the drug to the patients and monitoring the infusion rate
| Study group | Role | What they receive |
|---|---|---|
| Montherapy | Other | Thirty patients will receive IV Imipenem in doses of 15 to 25 mg/kg every 6 hours Receives: Drug: Tienam 500; Device: Infusion |
| Combination | Other | 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. Receives: Drug: Tienam 500; Device: Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic Parameters Measurement ,heart beating rate.
the efficacy and safety of antibiotic combination containing Colistin. We will monitor the heart beating rate.
Measured: 2 year
Hemodynamic Parameters Measurement ,body temperature
the efficacy and safety of antibiotic combination containing Colistin. We will monitor the body temperature
Measured: 2 year
Hemodynamic Parameters Measurement ,respiratory rate.
the efficacy and safety of antibiotic combination containing Colistin. We will monitor the respiratory rate.
Measured: 2 year
Hemodynamic Parameters Measurement ,blood pressure
the efficacy and safety of antibiotic combination containing Colistin. We will monitor the blood pressure
Measured: 2 year
Hemodynamic Parameters Measurement ,partial oxygen saturation pressure
the efficacy and safety of antibiotic combination containing Colistin. We will monitor the partial oxygen saturation pressure
Measured: 2 year
Hemodynamic Parameters Measurement and Septic Markers, serum lactate
the efficacy and safety of antibiotic combination containing Colistin. We will monitor the serum lactate
Measured: 2 year
Hemodynamic Parameters Measurement ,serum creatinine
the efficacy and safety of antibiotic combination containing Colistin. We will monitor the serum creatinine
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Sep 2017
- Primary completion1 Sep 2019
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepticemiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Saeed Attia Mancy, Ain Shams University
- Investigators
- AHMED S ATTIA, Principal investigator, Heliopolis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764058
- Sponsor's protocol ID
- 210
- Status last verified
- Feb 2021
- First submitted
- 15 Feb 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Colistin Based Antibiotic Therapy for Multidrug Resistant Gram Negative Infections in Pediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04764058
- Acronym / sponsor ID
- 210
- Conditions
- Septicemia, Bacterial Infections
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Montherapy | Other | Drug: Tienam 500, Device: InfusionThirty patients will receive IV Imipenem in doses of 15 to 25 mg/kg every 6 hours |
| Combination | Other | Drug: Tienam 500, Device: InfusionThirty 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All children with culture proven nosocomial infections due to multidrug resistance gram-negative organisms
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tienam 500Also: MeronemImipenem and cilastatin sodium | Drug | Combination, Montherapy |
| InfusionHealth caregivers give the drug to the patients and monitoring the infusion rate | Device | Combination, Montherapy |
Primary outcome
Hemodynamic Parameters Measurement ,heart beating rate.
Time frame: 2 year
the efficacy and safety of antibiotic combination containing Colistin. We will monitor the heart beating rate.
Hemodynamic Parameters Measurement ,body temperature
Time frame: 2 year
the efficacy and safety of antibiotic combination containing Colistin. We will monitor the body temperature
Hemodynamic Parameters Measurement ,respiratory rate.
Time frame: 2 year
the efficacy and safety of antibiotic combination containing Colistin. We will monitor the respiratory rate.
Hemodynamic Parameters Measurement ,blood pressure
Time frame: 2 year
the efficacy and safety of antibiotic combination containing Colistin. We will monitor the blood pressure
Hemodynamic Parameters Measurement ,partial oxygen saturation pressure
Time frame: 2 year
the efficacy and safety of antibiotic combination containing Colistin. We will monitor the partial oxygen saturation pressure
Hemodynamic Parameters Measurement and Septic Markers, serum lactate
Time frame: 2 year
the efficacy and safety of antibiotic combination containing Colistin. We will monitor the serum lactate
Hemodynamic Parameters Measurement ,serum creatinine
Time frame: 2 year
the efficacy and safety of antibiotic combination containing Colistin. We will monitor the serum creatinine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AHMED S ATTIA principal investigator
Heliopolis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tienam 500 and Infusion in people with Septicemia and Bacterial Infections, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamic Parameters Measurement ,heart beating rate. (time frame: 2 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.