Colistin Adverse ReactionNCT06472271
Colistin Dosage Prsonalization Approach
An observational study of Colistin Adverse Reaction, run by Mahmoud I Mostafa at 1 site in Egypt.
Trial summary
A few studies have evaluated higher doses or the administration or a loading dose, which is routine in adults, in pediatric patients, and reported improved colistin exposure without an increased risk of nephrotoxicity The main questions it aims to answer are What is the optimal dosing strategies of intravenous… Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Colistin Adverse Reaction
- What is being tested?
- Polymyxin e
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jul 2024to 30 Oct 2025
- How long will I take part?
- 21 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Preterm, critically-ill, neonates diagnosed with resistant gram-negative infections
Who may be able to join
- Neonates aged between (0-30 days) born before 37 weeks
- Critically ill patients with nosocomial infection with proven culture-resistant gram-negative bacteria.
- Neonates who are indicated for colistin and started colistin therapy for at least 48 hr.
Who cannot join
- Serum creatinine ≥1.5 baseline before colistin
- Received colistin before NICU stay
- Administration of concurrent nephrotoxic drugs including amphotericin, gentamicin, or amikacin.
- Major congenital anomalies or with previous renal impairment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo univrsity Hospitals
Cairo, 11435
Doaa Hamed, PHD, 01062963529, doaa.labib@cu.edu.eg
About this study
Official title: Colistin in Neonatal ICU Patients With Gram Negative Resistant Infection: Dosage Personalization Approach
A few studies have evaluated higher doses or the administration or a loading dose, which is routine in adults, in pediatric patients, and reported improved colistin exposure without an increased risk of nephrotoxicity The main questions it aims to answer are What is the optimal dosing strategies of intravenous colistin for the treatment of multidrug-resistant gram-negative bacterial infections in preterm neonates? What is the incidence of AKI? What is the factors increasing AKI incidence? A single center retrospective and comparative study, cohort study compare low dose 5 mg/kg/day versus 7.5mg/kg/day
Read the detailed description
Retrospective study to measure safety and efficacy of colistin conventional dose versus high dose then prospective design to measure pharmacokinetics parameter of both doses to design optimal dose
- Conditions
- Colistin Adverse Reaction
- Being tested
- Polymyxin e
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polymyxin eDrug
Also called Colistin
Increased starting colistin dose
| Study group | Role | What they receive |
|---|---|---|
| Conventional initial dose | Colistin 5mg/kg/day Receives: Drug: Polymyxin e | |
| High initial dose | Colistin 7.5mg/kg/day Receives: Drug: Polymyxin e |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response
Resolving signs and symptoms with normalized acute phase reactants in clinical septic patients
Measured: 21 days
Secondary outcomes (1)
Microbiological clearance
Negative culture results following Colistin therapy
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start30 Jul 2024
- Primary completion30 Nov 2024
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colistin Adverse ReactionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
- Target duration
- 21 Days
Sponsor and investigators
- Lead sponsor
- Mahmoud I Mostafa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahmoud I Mostafa, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472271
- Sponsor's protocol ID
- colistin in neonates
- Status last verified
- Aug 2025
- First submitted
- 18 Jun 2024
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colistin in Neonatal ICU Patients With Gram Negative Resistant Infection: Dosage Personalization Approach
- ClinicalTrials.gov ID
- NCT06472271
- Acronym / sponsor ID
- colistin in neonates
- Conditions
- Colistin Adverse Reaction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mahmoud I MostafaUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 25 Jun 2024 (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.
A few studies have evaluated higher doses or the administration or a loading dose, which is routine in adults, in pediatric patients, and reported improved colistin exposure without an increased risk of nephrotoxicity The main questions it aims to answer are What is the optimal dosing strategies of intravenous colistin for the treatment of multidrug-resistant gram-negative bacterial infections in preterm neonates? What is the incidence of AKI? What is the factors increasing AKI incidence? A single center retrospective and comparative study, cohort study compare low dose 5 mg/kg/day versus 7.5mg/kg/day
Detailed description
Retrospective study to measure safety and efficacy of colistin conventional dose versus high dose then prospective design to measure pharmacokinetics parameter of both doses to design optimal dose
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 21 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional initial dose | – | Drug: Polymyxin eColistin 5mg/kg/day |
| High initial dose | – | Drug: Polymyxin eColistin 7.5mg/kg/day |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm, critically-ill, neonates diagnosed with resistant gram-negative infections
Key inclusion criteria (3 listed)
- Neonates aged between (0-30 days) born before 37 weeks
- Critically ill patients with nosocomial infection with proven culture-resistant gram-negative bacteria.
- Neonates who are indicated for colistin and started colistin therapy for at least 48 hr.
Key exclusion criteria (4 listed)
- Serum creatinine ≥1.5 baseline before colistin
- Received colistin before NICU stay
- Administration of concurrent nephrotoxic drugs including amphotericin, gentamicin, or amikacin.
- Major congenital anomalies or with previous renal impairment.
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 |
|---|---|---|
| Polymyxin eAlso: ColistinIncreased starting colistin dose | Drug | Conventional initial dose, High initial dose |
Primary outcome
Clinical response
Time frame: 21 days
Resolving signs and symptoms with normalized acute phase reactants in clinical septic patients
1 secondary outcome
Microbiological clearance
Time frame: 21 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colistin Adverse Reaction, run by Mahmoud I Mostafa 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 13 Aug 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response (time frame: 21 days). 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 13 Aug 2025.