Staphylococcus IsolatesEarly Phase 1NCT04933019
Detection of Clindamycin Resistance Antibiotic Genes Among Staphylococcus Isolates by Using Real Time PCR
A Early Phase 1 study testing Detection of Clinclidamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR in people with Staphylococcus Isolates, run by Sohag University at 1 site in Egypt.
Trial summary
Detection of Clindamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Staphylococcus Isolates
- What is being tested?
- Detection of Clinclidamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2021to 1 Aug 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all staphylococcus isolates resistant to clindamycin
Who cannot join
- non
Trial locations and contacts
1 site in 1 country.
About this study
Detection of Clindamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR
Read the detailed description
Detection of Clindamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR
- Conditions
- Staphylococcus Isolates
- Being tested
- Detection of Clinclidamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of Clinclidamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCRGenetic
Detection of Clindamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR
| Study group | Role | What they receive |
|---|---|---|
| Clindamycin Resistance Genes among Staphylococcus Isolates by Using Real Time PCR | Other | Not described Receives: Genetic: Detection of Clinclidamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR |
| Clindamycin sensetive Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR | Other | Not described Receives: Genetic: Detection of Clinclidamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Clindamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR
Detection of Clindamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start1 Jul 2021 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus IsolatesStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alzahraa Nasser Mahmoud, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933019
- Sponsor's protocol ID
- Soh-Med-21-06-14
- Status last verified
- Jun 2021
- First submitted
- 13 Jun 2021
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Detection of Clindamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Clindamycin Resistance Antibiotic Genes Among Staphylococcus Isolates by Using Real Time PCR
- ClinicalTrials.gov ID
- NCT04933019
- Acronym / sponsor ID
- Soh-Med-21-06-14
- Conditions
- Staphylococcus Isolates
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 21 Jun 2021 (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.
Detection of Clindamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR
Detailed description
Detection of Clindamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clindamycin Resistance Genes among Staphylococcus Isolates by Using Real Time PCR | Other | Genetic: Detection of Clinclidamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR |
| Clindamycin sensetive Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR | Other | Genetic: Detection of Clinclidamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all staphylococcus isolates resistant to clindamycin
Key exclusion criteria (1 listed)
- non
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 |
|---|---|---|
| Detection of Clinclidamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCRDetection of Clindamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR | Genetic | Clindamycin Resistance Genes among Staphylococcus Isolates by Using Real Time PCR, Clindamycin sensetive Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR |
Primary outcome
Detection of Clindamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR
Time frame: 1 year
Detection of Clindamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Individual participant dataSharing planned: Undecided. Detection of Clindamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR
Related trials for Staphylococcus Isolates
Not yet recruitingObservational study
Gene Expression Analysis of Biofilm Formation and Antimicrobial Resistance in Clinical Methicillin-Resistant Staphylococcus Aureus
Staphylococcal Aureus Infection, Surgical Site Infection (SSI)
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.
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 Detection of Clinclidamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR in people with Staphylococcus Isolates, run by Sohag University 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Jun 2021. 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?
Results are not available in the source record.
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?
Detection of Clindamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR (time frame: 1 year). 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 21 Jun 2021.