Staphylococcal Infections Clinical Trial
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01447407 -
Effect of Adjuvant & Route of Administration on Safety & Immunogenicity of NDV-3 Vaccine
|
Phase 1 | |
| Recruiting |
NCT00518076 -
Staphylococcus Aureus Carriers Students Nursing Oxacillin Resistant
|
N/A | |
| Completed |
NCT01324440 -
Safety, Tolerability, and Immunogenicity of a Single Dose of Merck 0657nI Staphylococcus Aureus Vaccine With or Without Merck Aluminum Adjuvant (V710-002)
|
Phase 1 | |
| Completed |
NCT00501150 -
Oral Antibiotic Treatment at Home Instead of Intravenous Treatment in Hospital for Resistant Gram Positive Infections
|
N/A | |
| Completed |
NCT00071214 -
Study to Evaluate the Effectiveness of StaphVAX in Adults on Hemodialysis
|
Phase 3 | |
| Completed |
NCT00063089 -
Safety and Behavior of S. Aureus Immune Globulin Intravenous(Human), [Altastaph] in Patients With S. Aureus Bacteremia and Continuing Fever
|
Phase 1/Phase 2 | |
| Completed |
NCT00175370 -
Vancomycin Study: Treatment of Catheter Related Bloodstream Infection Caused by Coagulase Negative Staphylococcus
|
N/A | |
| Recruiting |
NCT03456544 -
Vancomycin-Associated Acute Kidney Injury: A Cross-Sectional Study From a Multi- Center in China
|
||
| Completed |
NCT02557568 -
Evaluation of an Algorithm for Identifying Persistent Nasal Staphylococcus Aureus Carriage in a Cohort of Healthy Volunteers and Patients Regularly Monitored at the CHU of Saint-Etienne
|
N/A | |
| Terminated |
NCT01196169 -
Daptomycin Use for Antimicrobial Prophylaxis in Methicillin Resistant Staphylococcus Aureus (MRSA) Colonized Adult Patients Undergoing Primary Elective Hip, Knee, or Shoulder Arthroplasty
|
Phase 4 | |
| Completed |
NCT01431326 -
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
|
||
| Completed |
NCT02971657 -
Bacterial Phenotype of Staphylococcus Aureus Has no Effect on Patients` Clinical Outcome in Orthopedic Device Related Bone Infections
|
N/A | |
| Completed |
NCT02640937 -
Biofilm Formation in Staphylococcus Epidermidis Associated Implant Infections
|
N/A | |
| Completed |
NCT00303069 -
V710 First-In-Man (FIM) Study (V710-001)
|
Phase 1 | |
| Completed |
NCT00156377 -
Prophylaxis With Intranasal Mupirocin for Prevention of S. Aureus Infections
|
Phase 4 | |
| Completed |
NCT00631566 -
Prospective Study of Methicillin-Resistant Staphylococcus Aureus (MRSA) Among HIV-Infected Persons
|
N/A | |
| Completed |
NCT00113191 -
Safety and Efficacy of Veronate® Versus Placebo in Preventing Nosocomial Staphylococcal Sepsis in Premature Infants
|
N/A | |
| Completed |
NCT02782078 -
Pharmacological Interaction of Rifampicin on Clindamycin in Staphylococcic Osteoarticular Infections
|
N/A | |
| Completed |
NCT00859677 -
Immunologic Predisposition of HIV Patients to Develop Methicillin-Resistant Staphylococcus Aureus (MRSA) Colonization and Infection
|
||
| Completed |
NCT00211900 -
Evaluation of Manufacturing Lot of StaphVAX
|
Phase 3 |