A Multi-center, Open-labelled, Randomized, Controlled, Extended Phase Ⅲ Clinical Trial of sIPV Vaccine
This is a multi-country, multi-center, open-labelled, randomized, controlled, extended phase Ⅲ clinical trial. Totally 1440 healthy infants of 6 weeks old (42-47 days) are planned to be enrolled, and then randomized in a 1:1:1:1 ratio into four groups, i.e., co-administration group 1 (group C1), co-administration group 2 (group C2), staggered administration group 1 (group S1) and staggered administration group 2 (group S2). Participants in group C1 and C2 will receive sIPV at 6,10, 14 weeks of age, administered concomitantly with routine infant vaccine (may include DTP-HepB-Hib vaccine, PCV10 or rotavirus vaccine in accordance with the local routine vaccination schedule). Participants in group S1 will receive sIPV at 6,10,14 weeks of age, and receive routine infant vaccines at 8,12,16 weeks of age. Participants in group S2 will receive routine infant vaccines at 6,10,14 weeks of age, and receive sIPV at 8,12, 16 weeks old. For all the Participants, the immediate reactions within 30 minutes after each dose of vaccination will be observed on site. Guardians of participants will utilize the diary card to record solicited adverse events from the time of vaccination for 7 days post-vaccination of each dose. From the time of the first vaccination and 28 days post-vaccination of the last dose, unsolicited adverse events and any SAEs will be required to recorded in the diary card. About 3 ml venous blood will be collected before the first vaccination and 28 days (+7) days after the last vaccination of sIPV or routine vaccines. Antibodies level will be determined using the collected sera for immunogenicity evaluation. Group C1 and S1 will be compared in terms of immunogenicity against polio; Group C2 and S2 will be compared in terms of immunogenicity against diphtheria, Tetanus, Pertussis, Hepatitis B, Hib and Pneumococcal.
Phase
3Span
80 weeksSponsor
Sinovac Biotech Co., LtdGujranwala
Recruiting
Healthy Volunteers
Comparison of Efficacy in Treating Breast Abscess, With Systemic Antibiotics Against Local Instillation of Antibiotics Along With Ultrasound Guided Aspiration.
A breast abscess is often characterized as a consequence of delayed or insufficient treatment following mastitis. The global prevalence of primary breast abscess in lactating women is estimated to be around 11%. In developing countries, where the quality of life and access to medical care may be limited, the prevalence of breast abscess tends to be higher. For instance, in Pakistan, the occurrence of breast abscess reaches up to 16%. This condition typically arises due to local inflammation and/or infection of the terminal lactiferous ducts. Mastitis, a precursor to breast abscess, can be attributed to factors such as poor hygiene, inadequate breastfeeding practices, milk stasis, cracked nipples, and the colonization of Staphylococcus aureus. Patients with breast abscess typically present with a painful, tender, and either focally or diffusely swollen breast. It is noteworthy that breast abscesses can be broadly classified into lactational and non-lactational types, each contributing significantly to morbidity in adult women. Several risk factors contribute to the development of both primary and recurrent lactational breast abscesses. These include increasing maternal age, obesity, primiparity, diabetes, smoking, and a history of mastitis. Additionally, rare predisposing factors encompass breast trauma, duct ectasia, fat necrosis, nipple piercing, and breast cancer. Staphylococcus aureus remains the most common causative organism, although E. Coli and H. Influenza have also been identified. Of particular concern is the rising prevalence of Methicillin-Resistant Staphylococcus Aureus (MRSA).The traditional approach to managing breast abscesses involves Incision & Drainage (I&D) accompanied by antibiotic therapy. However, this method is primarily reserved for complicated cases with skin changes such as ulceration, necrosis, or recurrent abscesses. In recent years, needle aspiration has emerged as the preferred treatment for uncomplicated cases. Clinical examination and radiological assessments using ultrasound or CT are crucial for establishing the diagnosis. Notably, the breast surgery community increasingly adopts needle aspiration as a minimally invasive technique for cases where the abscess size is less than 5cm on ultrasound, and symptoms have persisted for up to 5 days. Needle aspiration offers advantages such as avoiding hospital stays,eliminating the need for general anesthesia, and allowing continued breast feeding. It also reduces the risk of complications like milk fistulae. Factors such as multiple dressings for wound care, pain, dissatisfaction with cosmetic results, and delayed healing with I&D contribute to the growing acceptance of aspiration as a suitable alternative. Effective antimicrobial therapy is integral to the treatment of breast abscesses. Post I&D, antibiotic coverage is mandated for preventing Surgical Site Infection (SSI). The success of aspiration, similarly, hinges on judicious antimicrobial treatment. In an era marked by antibiotic resistance, providing effective and targeted antimicrobial therapy becomes crucial. Studies highlight the benefits of local instillation of antibiotics, demonstrating promising results in preventing SSIs and managing wounds and abscesses. Local instillation not only provides bypasses systemic administration but also reduces the need for postoperative systemic antibiotics. The concentration of antibiotics at the local site is higher when instilled locally, as evidenced by in vitro studies showing a 100% kill rate after only 60 seconds of exposure to the antibiotic irrigating solution. With advancement and diversity in the field of surgery, it is adapting to minimally invasive procedures with efficient out comes and conserving cosmetics. Aspiration for breast abscesses is replacing the conventional I&D to provide better care, fewer complications and better cosmetic results. In stemming the rise of resistance patterns antimicrobial stewardship has become surgical obligation. Some studies show that aspiration of the breast abscess with systemic antibiotics has a success rate of up to 94%, around 50%- 60% of the cases are recovered after single aspiration while some 20%-30% required a second time and rest needed multiple aspirations. The use of local instillation of antibiotics adjunct to aspiration in management of breast abscess may help limit the number of aspirations and recurrence, providing better cure and healing time for the patients. Abscess wall and edema makes it take longer to achieve MIC (minimal inhibitory concentration) than the local instillation. It can also help to limit the use of systemic antibiotics, and promote continued breast feeding. Combined they can not only cut down the morbidity but also prove to be better in treating the breast abscess and a key step against the emerging antibiotic resistance.
Phase
N/ASpan
31 weeksSponsor
Gujranwala medical college District Headquarters Hospital, GujranwalaGujranwala, Punjab
Recruiting