Last reviewed · How we verify
NCT04198649: AZITHROPARO
Effect of Azithromycin on Failure Proportion of Severe Periodontitis Non-surgical Treatment
Phase 3 trial testing Non-surgical periodontal treatment and azithromycin treatment in Severe Chronic Periodontitis in 6 participants. Terminated before completion.
2 November 2023
Quick facts
| Lead sponsor | University Hospital, Strasbourg, France |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 2 November 2021 |
| Primary completion | 2 November 2023 |
| Estimated completion | 2 November 2023 |
| Sites | 1 location across France |
Drugs / interventions tested
- Non-surgical periodontal treatment and azithromycin treatment — full drug profile →
- Non-surgical periodontal treatment and placebo treatment
Conditions studied
- Severe Chronic Periodontitis — all drugs for Severe Chronic Periodontitis →
Sponsor
University Hospital, Strasbourg, France
Who can join
35 and older, any sex, with Severe Chronic Periodontitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Primary purpose: Evaluate the effect of azithromycin on failure proportion of severe chronic periodontitis non-surgical treatment; failure characterized by the persistence of at least one periodontal pocket\> 5mm at 6 months Secondary purpose: * Evaluate the effect of azithromycin on the persistence of pathological periodontal pockets \> 5mm during non-surgical treatment of severe chronic periodontitis at 3 months and 6 months * Evaluate the effect of azithromycin on the changes of clinical signs, periopathogen levels, expression of macrolides resistance genes, and expression of antimicrobial peptides (PAMs) during treatment of severe chronic periodontitis at 3 months and 6 months * Assess therapeutic observance and side effects of antibiotic treatment * Assess at 3 and 6 months the potential interactions of local, bacterial (periopathogen and resistance gene) clinical factors, and host defense (PAMs) with the effect of azithromycin, on failure proportion of severe chronic periodontitis non-surgical treatment
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04198649
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other University Hospital, Strasbourg, France trials
Trials by the same sponsor.
- NCT07418554 — Sleep Disturbances in Children and Adolescents With Post-traumatic Stress Disorder (PTSD): a Randomized Double-blind Pla · Phase 3 · not yet recruiting
- NCT07108582 — Reducing Chronic Pain After Lung Surgery: A Trial of Limiting NSAIDs During Recovery · Phase 3 · not yet recruiting
- NCT07302646 — Optimizing Reduced-Flow, Low-Volume Contrast Protocols for Cerebral Angiography in Unruptured Aneurysms · NA · not yet recruiting
- NCT07273968 — Clinical Study Evaluating the Effect of Virtual Reality on Reducing Patients' Anxiety During Wisdom Teeth Extraction · NA · not yet recruiting
- NCT07214103 — Phase IIb Multicenter Randomized Controlled Trial Evaluating the Efficacy of Sivelestat in Patients With Septic Coagulop · Phase 2 · not yet recruiting
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 NCT04198649 (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 University Hospital, Strasbourg, France
- Last refreshed: 20 August 2024
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/NCT04198649.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing