Antibiotic Resistant InfectionEarly Phase 1NCT05442736
Modified Surface of PLGA Nanoparticles in Smart Hydrogel
A Early Phase 1 study testing Ciprofloxacin in people with Antibiotic Resistant Infection, run by British University In Egypt at 1 site in Egypt.
Trial summary
Nanoparticles containing antibiotic were prepared and incorporated in in situ gel to treat recurrent endodontic infections Read more about this study
- Who is it for?
- Ages 40 to 45 years
- Conditions the study is for
- Antibiotic Resistant Infection
- What is being tested?
- Ciprofloxacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Apr 2022to 16 Apr 2022
- Phase
- Early Phase 1
- 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 40 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Root canal filled single rooted teeth with post treatment disease manifested by one or more of the following signs and symptoms:
- History of recurrent acute and/or chronic periapical abscess
- Pain on palpation and/or percussion at least after one month of previous procedure
- Radiographic evidence of bone loss either as a new developing lesion or an increase in the size of a pre-existing one.
Who cannot join
- Teeth that were badly broken down indicated for extraction or with difficult isolation
- Immuno-compromised patients.
- Patients with history of taking antibiotics orally.
- Periodontally affected teeth.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modified Surface of PLGA Nanoparticles in Smart Hydrogel: A Randomized Clinical Trial to Establish an Advanced Strategy Against Antibiotic Resistant Infections in Endodontics
Nanoparticles containing antibiotic were prepared and incorporated in in situ gel to treat recurrent endodontic infections
Read the detailed description
Enterococcus faecalis is the main cause of endodontic infections and form biofilm on dentin, resulting in treatment-resistant periradicular lesions. To overcome these problems, antibacterial nanoparticles were used because of their small size, sustained release and positive charge which interact with the negatively charged surface of bacterial cell causing its destruction. In this light, Ciprofloxacin hydrochloride (CIP) in chitosan coated PLGA nanoparticles (CIP-CS-PLGA-NPs) and free CIP were embedded in Pluronic® 407/188 to form thermosensitive gels(F1) and (F2) respectively, that were investigated in terms of viscosity, gelation temperature and in-vitro release. The antibacterial efficacy of F1 and F2 were clinically investigated on patients then compared to CIP and Ca(OH)2 pastes by determining bacterial reduction percent and biofilm inhibition assay
- Conditions
- Antibiotic Resistant Infection
- Being tested
- Ciprofloxacin
- Keywords
- nanoparticles, endodontics infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofloxacinDrug
Also called device
studying the effect of nanoparticles in controlling the release of the drug in addition to in situ gel
| Study group | Role | What they receive |
|---|---|---|
| Free drug | Active comparator | Free drug incorporated in in situ gels Receives: Drug: Ciprofloxacin |
| drug entrapped in nanoparticles | Active comparator | drug entrapped in nanoparticles then incorporated in in situ gels Receives: Drug: Ciprofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
controlled release of the drug with associated with infection inhibition
drug entrapped in nanoparticles incorporated in in situ gel inhibited the biofilm formation and bacterial recurrent infection
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start2 Apr 2022
- Primary completion16 Apr 2022
- Study completion16 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antibiotic Resistant InfectionStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Fifty-five patients having single rooted teeth with signs and/or symptoms of post treatment disease that were indicated for non-surgical root canal retreatment were participated in this study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Gamal Mohamed Afifi Arafa, British University In Egypt
- Investigators
- Mona Arafa, Principal investigator, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442736
- Sponsor's protocol ID
- PI (1643)
- Status last verified
- Jun 2022
- First submitted
- 27 Jun 2022
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fereig SA, El-Zaafarany GM, Arafa MG, Abdel-Mottaleb MMA. Tackling the various classes of nano-therapeutics employed in topical therapy of psoriasis. Drug Deliv. 2020 Dec;27(1):662-680. doi: 10.1080/10717544.2020.1754527.
PubMed 32393082
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Surface of PLGA Nanoparticles in Smart Hydrogel: A Randomized Clinical Trial to Establish an Advanced Strategy Against Antibiotic Resistant Infections in Endodontics
- ClinicalTrials.gov ID
- NCT05442736
- Acronym / sponsor ID
- PI (1643)
- Conditions
- Antibiotic Resistant Infection
- Keywords
- nanoparticles, endodontics infection
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 2 Apr 2022 (actual)
- Primary completion
- 16 Apr 2022 (actual)
- Study completion
- 16 Apr 2022 (actual)
- First posted
- 5 Jul 2022 (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.
Nanoparticles containing antibiotic were prepared and incorporated in in situ gel to treat recurrent endodontic infections
Detailed description
Enterococcus faecalis is the main cause of endodontic infections and form biofilm on dentin, resulting in treatment-resistant periradicular lesions. To overcome these problems, antibacterial nanoparticles were used because of their small size, sustained release and positive charge which interact with the negatively charged surface of bacterial cell causing its destruction. In this light, Ciprofloxacin hydrochloride (CIP) in chitosan coated PLGA nanoparticles (CIP-CS-PLGA-NPs) and free CIP were embedded in Pluronic® 407/188 to form thermosensitive gels(F1) and (F2) respectively, that were investigated in terms of viscosity, gelation temperature and in-vitro release. The antibacterial efficacy of F1 and F2 were clinically investigated on patients then compared to CIP and Ca(OH)2 pastes by determining bacterial reduction percent and biofilm inhibition assay
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Fifty-five patients having single rooted teeth with signs and/or symptoms of post treatment disease that were indicated for non-surgical root canal retreatment were participated in this study
| Arm | Type | Receives |
|---|---|---|
| Free drug | Active comparator | Drug: CiprofloxacinFree drug incorporated in in situ gels |
| drug entrapped in nanoparticles | Active comparator | Drug: Ciprofloxacindrug entrapped in nanoparticles then incorporated in in situ gels |
Who may qualify
- Ages
- 40 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Root canal filled single rooted teeth with post treatment disease manifested by one or more of the following signs and symptoms:
- History of recurrent acute and/or chronic periapical abscess
- Pain on palpation and/or percussion at least after one month of previous procedure
- Radiographic evidence of bone loss either as a new developing lesion or an increase in the size of a pre-existing one.
Key exclusion criteria (4 listed)
- Teeth that were badly broken down indicated for extraction or with difficult isolation
- Immuno-compromised patients.
- Patients with history of taking antibiotics orally.
- Periodontally affected teeth.
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 |
|---|---|---|
| CiprofloxacinAlso: devicestudying the effect of nanoparticles in controlling the release of the drug in addition to in situ gel | Drug | Free drug, drug entrapped in nanoparticles |
Primary outcome
controlled release of the drug with associated with infection inhibition
Time frame: two weeks
drug entrapped in nanoparticles incorporated in in situ gel inhibited the biofilm formation and bacterial recurrent infection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Results publication: PubMed 32393082Fereig SA, El-Zaafarany GM, Arafa MG, Abdel-Mottaleb MMA. Tackling the various classes of nano-therapeutics employed in topical therapy of psoriasis. Drug Deliv. 2020 Dec;27(1):662-680. doi: 10.1080/10717544.2020.1754527.
- Individual participant dataSharing planned: No
Related trials for Antibiotic Resistant Infection
Recruiting
INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionS
Drug Resistance, Microbial, Biomarkers
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
Not yet recruitingObservational study
Targeted Antimicrobial Comparison for Treatment Individualization in Critically Ill Patients With CRAB Infection
Carbapenem-Resistant Acinetobacter Baumannii Infection
Not yet recruitingObservational study
Comparative Study of the Genomic Characteristics of Uropathogenic Escherichia Coli According to the Severity of Community-Acquired Urinary Tract Infections in Guadeloupe (COLIGENURI)
Urinary Tract Infections
Not yet recruiting
Farm-originated Antimicrobial Resistance Modeling: Exploring Humans-to-Animal Dissemination
Methicillin Resistance in Staphylococcus Aureus (MRSA)
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.
Mona Arafa principal investigator
British University In Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ciprofloxacin in people with Antibiotic Resistant Infection, run by British University In Egypt 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 4 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: finished, as of the sponsor's last update on 5 Jul 2022. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
controlled release of the drug with associated with infection inhibition (time frame: two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05442736, which also lists 1 linked publication.
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 5 Jul 2022.