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NCT07503600
The Effect of Adjunctive Melatonin With Colistin in Patients With Multidrug-Resistant Gram-Negative Bacterial Infections
Phase 3 trial testing Melatonin in Multidrug-Resistant Gram-Negative Bacterial Infections in 70 participants. Not yet recruiting.
26 August 2026
Quick facts
| Lead sponsor | Ain Shams University |
|---|---|
| Phase | Phase 3 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | supportive care |
| Enrollment | 70 |
| Start date | 26 March 2026 |
| Primary completion | 26 August 2026 |
| Estimated completion | 26 August 2026 |
Drugs / interventions tested
- Melatonin (MELATONIN) — full drug profile →
- Placebo
Conditions studied
- Multidrug-Resistant Gram-Negative Bacterial Infections — all drugs for Multidrug-Resistant Gram-Negative Bacterial Infections →
- Antimicrobial Resistance — all drugs for Antimicrobial Resistance →
Sponsor
Ain Shams University
Who can join
Adults 18 to 70, any sex, with Multidrug-Resistant Gram-Negative Bacterial Infections or Antimicrobial Resistance. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study evaluates whether adding melatonin to standard colistin therapy improves outcomes in patients with multidrug-resistant (MDR) Gram-negative bacterial infections. These infections are difficult to treat and are associated with high morbidity and mortality, particularly in critically ill patients. Colistin is often used as a last-line antibiotic for these infections; however, its effectiveness may be limited, and it is associated with side effects such as kidney injury. Melatonin, a naturally occurring hormone, has antioxidant, anti-inflammatory, and immune-modulating properties that may enhance the effectiveness of antibiotics and reduce treatment-related complications. In this randomized, double-blind, placebo-controlled study, adult patients receiving colistin will be assigned to receive either melatonin or a placebo in addition to standard care. The study will assess whether melatonin improves oxidative stress, infection control, and clinical outcomes while maintaining safety.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07503600
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Related trials
Other trials of Melatonin
Trials testing the same drug.
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- NCT07305350 — EFFICACY OF MELATONIN IN MANAGEMENT OF HYPOXIC ISCHEMIC ENCEPHALOPATHY (HIE) IN NEONATES · Phase 2 · active not recruiting
- NCT07375342 — Melatonin for Post Tonsillectomy Emergence Agitation in Pediatric · NA · enrolling by invitation
- NCT07096635 — Oral Melatonin With Intra Articular Analgesia on Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction · NA · not yet recruiting
- NCT07475156 — The Effect of Dexmedetomidine Infusion Alone Versus the Combination of Dexmedetomidine and Melatonin on Reduction of Pos · Phase 4 · completed
Other Ain Shams University trials
Trials by the same sponsor.
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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 NCT07503600 (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 Ain Shams University
- Last refreshed: 31 March 2026
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/NCT07503600.
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