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NCT02162966
Use Of High Dose Colistin in Multi Drug Resistant Gram Negative Infections in Critically Ill Adult Patients. Randomized Controlled Clinical Trial
Phase 4 trial testing High Dose Colistin in Infectious Diseases in 330 participants. Status unknown.
1 October 2016
Quick facts
| Lead sponsor | King Saud Medical City |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 330 |
| Start date | 1 May 2014 |
| Primary completion | 1 October 2016 |
| Estimated completion | 1 October 2016 |
| Sites | 1 location across Saudi Arabia |
Drugs / interventions tested
- High Dose Colistin — full drug profile →
- Standard Dose Colistin — full drug profile →
Conditions studied
- Infectious Diseases — all drugs for Infectious Diseases →
Sponsor
King Saud Medical City — full company profile →
Who can join
18 and older, any sex, with Infectious Diseases. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Evaluate safety of high dose Colistin
Time frame: 7 to 21 days after giving Colistin
Evaluate the safety of high dose Colistin to treat MDRO infection in critically ill patients. The safety of high dose Colistin will be determined by number of participants whom renal function will be deviated from the baseline after administering high dose of Colistin.
Sponsor's own description
Colistin is a rapidly acting bactericidal antimicrobial agent that possesses a post antibiotic effect against MDRO Gram-negative bacteria, such as as Pseudomonas aeruginosa, Acinetobacterbaumannii, and Klebsiella pneumonia.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02162966
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other King Saud Medical City trials
Trials by the same sponsor.
- NCT06755203 — Evaluating the Impact of Operating Room Simulations on Communication Skills and Patient Safety (EIORS-CPS) · recruiting
- NCT06748131 — Efficiency of Operating Room Simulation for Training Medical Students at King Saud University (EORMST-KSU) · active not recruiting
- NCT06088082 — "Analgesic Efficacy of Combined Transversus Abdominis Plane Block and Posterior Rectus Sheath Block in Patients Undergoi · Phase 3 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02162966 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by King Saud Medical City
- Last refreshed: 31 March 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02162966.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing