Skin InfectionPhase 4SoTiClinNCT05899140
Adjunctive Clindamycin for the Treatment of Skin and Soft Tissue Infections, a Randomized Controlled Trial
A Phase 4 study testing Clindamycin in people with Skin Infection and Staphylococcal Infections, run by Frieder Schaumburg at 1 site in Sierra Leone.
Trial summary
This is an exploratory study to evaluate the effect of adjunctive clindamycin in the treatment of skin and soft-tissue infections due to Staphylococcus aureus in patients from Sierra Leone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Infection, Staphylococcal Infections, Staphylococcus Aureus Infection
- What is being tested?
- Clindamycin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSierra Leone
- Study dates
- 15 Mar 2024to 31 Jul 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (age ≥18 years);
- Need for a treatment (incision/drainage ± antibiotic treatment po or iv) of an SSTI;
- S. aureus causing SSTI identified from at least one clinical specimen (including isolation in polymicrobial cultures if S. aureus is considered to be the leading pathogen);
- Onset of symptoms within the last 4 weeks;
- Randomisation possible within 72 hours from collection of the initial culture
- Ability to conduct the follow-up visits either during admission or at home
- Initial culture collected within 48 hours of hospital admission
- Willingness to participate in the study.
Who cannot join
- Previous allergic reaction to clindamycin
- Previous antibiotic-associated diarrhea
- Previous study participation
- Pregnancy as confirmed by a beta-HCG rapid test.
- Started treatment with clindamycin prior to clinic presentation;
- Documented systemic antibiotic treatment within the previous 14 days
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- Co-administration of other protein synthesis inhibitors (e.g. macrolides, rifampicin, linezolid, aminoglycosides, tetracyclines, chloramphenicol);
- Co-administration of toxin inducers (trimethoprim-sulfamethoxazole)
- Severe illness (patient expected to die in the following 24 hrs);
- Chronically infected wounds (>4 weeks of symptoms);
- Infections associated with any of the following (due to mixed infection): a) Human or animal bites;b) Prosthetic or implantable devices; c) Decubitus ulcers; d) Diabetic foot ulcers, infected ulcers secondary to peripheral artery disease, chronic venous insufficiency; e) Suspected Buruli ulcer; f) Infected burns.
- Hospital-acquired infection including post-surgical site infections
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ioana D Olaru, PhD contact
Sierra Leone1 site, 1 recruiting
- Recruiting
Masanga Hospital
Masokori
Emmanuel M Kanu, MB BS
About this study
Official title: Adjunctive Clindamycin Versus Standard of Care for the Treatment of Skin and Soft Tissue Infections, a Randomized Controlled, Open-label Superiority Phase 4 Trial
This is an exploratory study to evaluate the effect of adjunctive clindamycin in the treatment of skin and soft-tissue infections due to Staphylococcus aureus in patients from Sierra Leone. The study hypothesizes that clindamycin, when added to routine treatment, will lead to a more rapid clinical resolution and less frequent recurrences of infection.
Read the detailed description
Panton-Valentine Leukokidin and other toxins play an important role in the severity of skin and soft-tissue infections due to Staphylococcus aureus. The inhibition of the protein synthesis could be beneficial, due to the major role of protein-toxins in the pathogenesis of skin and soft tissue infections. Clindamycin has a strong toxin-suppressive activity. Therefore, clindamycin is currently considered as the most-promising adjuvant antimicrobial agent in the treatment of toxin-mediated S. aureus infections. Recurrent infections are common in patients with S. aureus skin and soft-tissue infections. Clindamycin has been reported to reduce S. aureus colonisation, which may in turn reduce the risk for recurrent infections. Clindamycin is an already approved antimicrobial used for a wide range of indications and with a known safety profile.
This study is an investigator-led, investigator-initiated, open-label superiority randomised controlled trial that will be conducted at Masanga Hospital in Sierra Leone. The objectives of this study are to determine the feasibility, efficacy and safety of adjunctive clindamycin therapy (in addition to standard-of-care) compared to standard-of-care alone on clinical treatment outcomes in patients with skin and soft tissue infections due to S. aureus in Sierra Leone. This is a preliminary study, which will include 100 adult participants with skin and soft-tissue infections requiring systemic therapy.
- Being tested
- Clindamycin, Standard of care
- Keywords
- SSTI, Staphylococcus aureus, Panton-Valentine leukocidin
- Medical subject headings
- Cellulitis, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClindamycinDrug
Clindamycin will be administered at a dose of 450 mg TDS (oral) or 10 mg/kg/dose QID iv (maximum 600mg QID iv) for a maximum of 7 days
Standard of careOther
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Other | Participants with skin and soft-tissue infections requiring systemic treatment (oral or intravenous). Treatment according to local guidelines = standard of care: usually an anti-staphylococcal penicillin with or without incision and drainage, as required.
Treatment can be with (local guidelines) cloxacillin (non-severe) po 500g QIDfor 5-7 days ceftriaxone (severe infections) 2g iv OD with step-down to cloxacillin po 500 mg QID for a total of 7 days Receives: Other: Standard of care |
| Standard of care + clindamycin | Active comparator | Participants with skin and soft-tissue infections requiring systemic treatment (oral or intravenous).
Addition of clindamycin: 10 mg/kg/dose QID iv (maximum 600mg QID iv) or oral clindamycin 450 mg TDS for adults for a total of 7 days from randomisation. Receives: Drug: Clindamycin; Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure at follow-up 7 days
Proportion of patients with clinical cure defined as the absence of clinical failure
Measured: Day 7
Secondary outcomes (7)
Change in inflammatory markers under therapy
Change in mean C-reactive protein level
Measured: from baseline to Day 3 and from baseline to Day 7
Time to symptom resolution
Time to resolution of symptoms
Measured: during follow-up up to day 14
Occurence of adverse events
Proportion of patients with adverse events (of any kind) and of adverse events that required treatment discontinuation or change in drugs used
Measured: anytime during follow-up (to day 14)
Microbiological failure
Proportion of microbiological treatment failure (culture of S. aureus in relevant materials) on Day 3 and Day 7;
Measured: during follow-up day 3 and day 7
Clostridioides difficile associated diarrhoea
Proportion with Clostridioides difficile associated diarrhoea
Measured: during follow-up, up to day 14
Recurrent infections
Proportion of recurrent infections during a passive follow up of 6 months
Measured: 6 months passive follow-up (participant re-presents to clinic)
Clinical cure at follow-up 14 days
Proportion of patients with clinical cure defined as the absence of clinical failure
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start15 Mar 2024
- Primary completion29 Mar 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-arm randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frieder Schaumburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Frieder Schaumburg, Universität Münster
- Investigators
- Frieder Schaumburg, MD, Principal investigator, Universität Münster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899140
- Sponsor's protocol ID
- SoTiClin
- Acronym
- SoTiClin
- Status last verified
- Dec 2024
- First submitted
- 22 May 2023
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is currently being considered and the information will be updated once a decision has been reached
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Clindamycin Versus Standard of Care for the Treatment of Skin and Soft Tissue Infections, a Randomized Controlled, Open-label Superiority Phase 4 Trial
- ClinicalTrials.gov ID
- NCT05899140
- Acronym / sponsor ID
- SoTiClin / SoTiClin
- Keywords
- SSTI, Staphylococcus aureus, Panton-Valentine leukocidin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Frieder SchaumburgUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 29 Mar 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 12 Jun 2023 (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.
This is an exploratory study to evaluate the effect of adjunctive clindamycin in the treatment of skin and soft-tissue infections due to Staphylococcus aureus in patients from Sierra Leone. The study hypothesizes that clindamycin, when added to routine treatment, will lead to a more rapid clinical resolution and less frequent recurrences of infection.
Detailed description
Panton-Valentine Leukokidin and other toxins play an important role in the severity of skin and soft-tissue infections due to Staphylococcus aureus. The inhibition of the protein synthesis could be beneficial, due to the major role of protein-toxins in the pathogenesis of skin and soft tissue infections. Clindamycin has a strong toxin-suppressive activity. Therefore, clindamycin is currently considered as the most-promising adjuvant antimicrobial agent in the treatment of toxin-mediated S. aureus infections. Recurrent infections are common in patients with S. aureus skin and soft-tissue infections. Clindamycin has been reported to reduce S. aureus colonisation, which may in turn reduce the risk for recurrent infections. Clindamycin is an already approved antimicrobial used for a wide range of indications and with a known safety profile.
This study is an investigator-led, investigator-initiated, open-label superiority randomised controlled trial that will be conducted at Masanga Hospital in Sierra Leone. The objectives of this study are to determine the feasibility, efficacy and safety of adjunctive clindamycin therapy (in addition to standard-of-care) compared to standard-of-care alone on clinical treatment outcomes in patients with skin and soft tissue infections due to S. aureus in Sierra Leone. This is a preliminary study, which will include 100 adult participants with skin and soft-tissue infections requiring systemic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2-arm randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Other | Other: Standard of careParticipants with skin and soft-tissue infections requiring systemic treatment (oral or intravenous). Treatment according to local guidelines = standard of care: usually an anti-staphylococcal penicillin with or without incision and drainage, as required. Treatment can be with (local guidelines) cloxacillin (non-severe) po 500g QIDfor 5-7 days ceftriaxone (severe infections) 2g iv OD with step-down to cloxacillin po 500 mg QID for a total of 7 days |
| Standard of care + clindamycin | Active comparator | Drug: Clindamycin, Other: Standard of careParticipants with skin and soft-tissue infections requiring systemic treatment (oral or intravenous). Addition of clindamycin: 10 mg/kg/dose QID iv (maximum 600mg QID iv) or oral clindamycin 450 mg TDS for adults for a total of 7 days from randomisation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults (age ≥18 years);
- Need for a treatment (incision/drainage ± antibiotic treatment po or iv) of an SSTI;
- S. aureus causing SSTI identified from at least one clinical specimen (including isolation in polymicrobial cultures if S. aureus is considered to be the leading pathogen);
- Onset of symptoms within the last 4 weeks;
- Randomisation possible within 72 hours from collection of the initial culture
Key exclusion criteria (12 listed)
- Previous allergic reaction to clindamycin
- Previous antibiotic-associated diarrhea
- Previous study participation
- Pregnancy as confirmed by a beta-HCG rapid test.
- Started treatment with clindamycin prior to clinic presentation;
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 |
|---|---|---|
| ClindamycinClindamycin will be administered at a dose of 450 mg TDS (oral) or 10 mg/kg/dose QID iv (maximum 600mg QID iv) for a maximum of 7 days | Drug | Standard of care + clindamycin |
| Standard of careStandard of care | Other | Standard of care, Standard of care + clindamycin |
Primary outcome
Clinical cure at follow-up 7 days
Time frame: Day 7
Proportion of patients with clinical cure defined as the absence of clinical failure
7 secondary outcomes
Change in inflammatory markers under therapy
Time frame: from baseline to Day 3 and from baseline to Day 7
Time to symptom resolution
Time frame: during follow-up up to day 14
Occurence of adverse events
Time frame: anytime during follow-up (to day 14)
Microbiological failure
Time frame: during follow-up day 3 and day 7
Clostridioides difficile associated diarrhoea
Time frame: during follow-up, up to day 14
Recurrent infections
Time frame: 6 months passive follow-up (participant re-presents to clinic)
Clinical cure at follow-up 14 days
Time frame: Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No. This is currently being considered and the information will be updated once a decision has been reached
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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.
Ioana D Olaru, PhD contact
Frieder Schaumburg, MD principal investigator
Universität Münster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clindamycin in people with Skin Infection and Staphylococcal Infections, run by Frieder Schaumburg at 1 site in Sierra Leone.
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 8 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 9 Dec 2024. 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 Sierra Leone. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frieder Schaumburg, MD (+492518352767, frieder.schaumburg@ukmuenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure at follow-up 7 days (time frame: Day 7). 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 9 Dec 2024.