The Safety and Efficacy of Dalbavancin and Active Comparator in Pediatric Patients With Acute Bacterial Skin and Skin Structure Infections.

BACKGROUND: Acute bacterial skin and skin structure infections (ABSSSIs) are a significant source of morbidity in children. Dalbavancin, approved for the treatment of adults and children with ABSSSI, has a well-established safety profile in adults. We report safety and descriptive efficacy data for the treatment of ABSSSI in children. METHODS: Children with ABSSSI (birth-<18 years old) or sepsis (<3 months old) known/suspected to be caused by susceptible Gram-positive organisms were enrolled in this phase 3, multicenter, open-label, comparator-controlled study (NCT02814916). Children ≥3 months old were randomized 3:3:1 to receive single-dose dalbavancin, 2-dose dalbavancin, or a comparator antibiotic in 4 age cohorts; those <3 months old received single-dose dalbavancin. Clinical response and microbiologic efficacy were evaluated 48-72 hours and 14, 28 and 54 days posttreatment. Bowel flora testing and audiology were collected in a subset of patients at baseline and day 28. Adverse events (AEs) were collected throughout the study. RESULTS: Treatment-emergent AEs occurred in 7.2%, 9.0% and 3.3% of patients in dalbavancin single-dose, dalbavancin 2-dose and comparator arms, respectively. Three serious AEs occurred in the dalbavancin single-dose arm; no treatment-related AEs, serious AEs, or AEs leading to study discontinuation were reported. Favorable clinical response at 48-72 hours was documented in 97.4%, 98.6% and 89.7% of patients. Safety and efficacy were comparable across age cohorts. The microbiologic intent-to-treat population had comparable clinical response for all baseline pathogens, including methicillin-resistant Staphylococcus aureus . CONCLUSION: The safety profile of dalbavancin was consistent in children and adults with ABSSSI. No new safety signals were identified.

Extrahepatic Portal Vein Thrombosis in Childhood: Risk Factors, Clinical Manifestations, and Management.

OBJECTIVE: Extrahepatic portal vein thrombosis (EHPVT) is a common cause of portal hypertension in children. The aim of the present study was to identify the clinical manifestations and the risk factors for development of EHPVT in pediatric patients. SUBJECTS AND METHODS: This was a single-center retrospective cohort study. A total of 12 children (6 boys and 6 girls) took part in the study. We noted the clinical presentations and the predisposing risk factors for development of EHPVT in all patients. In addition, as all of them had undergone an esophagogastroduodenoscopy for detection and grading of esophageal varices as part of the treatment algorithm, we analyzed the endoscopic findings and the therapeutic approach. RESULTS: The median age of subjects at diagnosis was 3.5 years (range: 1-17 years). The most frequent initial clinical manifestation was upper gastrointestinal bleeding (6 cases, 50.0%) followed by splenomegaly (3 cases, 25.0%). The most frequent systemic risk factor for EHPVT was presence of inherited prothrombotic disorder (10 cases, 83.3%), and the most common local risk factor for EHPVT was umbilical vein catheterization (5 cases, 41.7%). Esophageal varices were revealed in all the study participants, and in the most cases, they were grade ≥2. Propranolol was used as primary or secondary prophylaxis in 7 children (58.3%), and in 5 children (41.7%), a shunt was performed (Meso-Rex bypass in 3 children and splenorenal shunt in 2 children). CONCLUSION: Patients with known systemic or local risk factors for EHPVT are indicated for proactive ultrasound screening for early diagnosis and timely management.

Gallbladder polyp in children - a rare finding during ultrasound examination.

Gallbladder polyps are a relatively rare finding in children. The increased use of high-resolution ultrasound in childhood allows to detect gallbladder lesions in young patients. A precise diagnosis can be established using different imaging series. Abdominal contrast-enhanced ultrasound examination provides the most accurate imaging information about the nature and size of the lesion. This is important for further decisions regarding patient referral for cholecystectomy. The object of this study was to present a case of gallbladder polyp diagnosed and followed up by contrast-enhanced ultrasound.

Minimally Invasive Supraumbilical Approach for Pyloromyotomy.

BACKGROUND: The three major approaches for Ramstedt pyloromyotomy - right upper quadrant incision, supraumbilical incision and laparoscopic method, are often compared, with some preference given to the supraumbilical approach. It becomes widely adopted in many centers around the world. AIM: To analyse the early results of the supraumbilical incision in treatment of hypertrophic pyloric stenosis and to test a hypothesis that this technique may be valuable in our clinical conditions. MATERIALS AND METHODS: Within a ten-month period five children with hypertrophic pyloric stenosis were selected (using single random sample) for pyloromyotomy via supraumbilical incision and another five children - via Robertson incision. This technique consists of semi lunar cutting in the upper half of umbilicus, extended cranially in the midline. After a Ramstedt pyloromyotomy, linea alba is sutured and the reshaped skin is sutured in semilunar manner around the umbilicus. The scar was estimated with Patient and Observer Scar Assessment Scale. RESULTS: The operations were performed by pediatric surgeons with different experience and with basic equipment. The operative time was 5-10 min longer for the supraumbilical incision. The pyloromyotomy led to a definitive healing, with timely feeding and discharging, without any complication. The quality of the scar was significantly better after the supraumbilical incision. CONCLUSION: Supraumbilical incision is reliable and related to low complication rates. It leaves better scar than the Robertson incision and is an excellent alternative in search for less invasive techniques.

Striving for Better Medical Education: the Simulation Approach.

Medical simulation is a rapidly expanding area within medical education due to advances in technology, significant reduction in training hours and increased procedural complexity. Simulation training aims to enhance patient safety through improved technical competency and eliminating human factors in a risk free environment. It is particularly applicable to a practical, procedure-orientated specialties. Simulation can be useful for novice trainees, experienced clinicians (e.g. for revalidation) and team building. It has become a cornerstone in the delivery of medical education, being a paradigm shift in how doctors are educated and trained. Simulation must take a proactive position in the development of metric-based simulation curriculum, adoption of proficiency benchmarking definitions, and should not depend on the simulation platforms used. Conversely, ingraining of poor practice may occur in the absence of adequate supervision, and equipment malfunction during the simulation can break the immersion and disrupt any learning that has occurred. Despite the presence of high technology, there is a substantial learning curve for both learners and facilitators. The technology of simulation continues to advance, offering devices capable of improved fidelity in virtual reality simulation, more sophisticated procedural practice and advanced patient simulators. Simulation-based training has also brought about paradigm shifts in the medical and surgical education arenas and ensured that the scope and impact of simulation will continue to broaden.

Central Nervous System Involvement in Henoch-Schonlein Purpura in Children and Adolescents.

Central nervous system (CNS) involvement in Henoch-Schonlein purpura (HSP) is rare but poses diagnostic difficulties. The aim of the study was to establish the frequency of CNS involvement in HSP, to analyze its clinical characteristics and do a literature review. Medical files of patients with HSP admitted at the Department of Pediatrics, Plovdiv, were studied retrospectively for a five-year period (2009-2013). Diagnosis was based on the American College of Rheumatology criteria. Out of 112 children with HSP 1 case (0.9%) had CNS involvement presenting as Posterior Reversible Encephalopathy Syndrome (PRES), which may be a result of CNS vasculitis or arterial hypertension. It was an 8-year-old girl with atypical HSP which started with abdominal pain requiring surgery. On the third day after the operation a transient macular rash and arterial hypertension appeared, followed by visual disturbances, hemiconvulsive epileptic seizures, postictal hemiparesis, and confusion. Head CT showed occipital hypodense lesions and MRT-T2 hyperintense lesion in the left occipital lobe. The patient experienced a second similar episode after 2 weeks when palpable purpura had also appeared. Neurological symptoms and MRI resolved completely. HSP can be an etiological factor for PRES in childhood. Although PRES is a rare complication of HSP, clinicians must be aware of it and avoid diagnostic and therapeutic delays.

Phase 2, randomized, double-blind study of the efficacy and safety of two dose regimens of eravacycline versus ertapenem for adult community-acquired complicated intra-abdominal infections.

Eravacycline is a novel fluorocycline, highly active against Gram-positive and Gram-negative pathogens in vitro, including those with tetracycline and multidrug resistance. This phase 2, randomized, double-blind study was conducted to evaluate the efficacy and safety of two dose regimens of eravacycline compared with ertapenem in adult hospitalized patients with complicated intra-abdominal infections (cIAIs). Patients with confirmed cIAI requiring surgical or percutaneous intervention and antibacterial therapy were randomized (2:2:1) to receive eravacycline at 1.5 mg/kg of body weight every 24 h (q24h), eravacycline at 1.0 mg/kg every 12 h (q12h), or ertapenem at 1 g (q24h) for a minimum of 4 days and a maximum of 14 days. The primary efficacy endpoint was the clinical response in microbiologically evaluable (ME) patients at the test-of-cure (TOC) visit 10 to 14 days after the last dose of study drug therapy. Overall, 53 patients received eravacycline at 1.5 mg/kg q24h, 56 received eravacycline at 1.0 mg/kg q12h, and 30 received ertapenem. For the ME population, the clinical success rate at the TOC visit was 92.9% (39/42) in the group receiving eravacycline at 1.5 mg/kg q24h, 100% (41/41) in the group receiving eravacycline at 1.0 mg/kg q12h, and 92.3% (24/26) in the ertapenem group. The incidences of treatment-emergent adverse events were 35.8%, 28.6%, and 26.7%, respectively. Incidence rates of nausea and vomiting were low in both eravacycline groups. Both dose regimens of eravacycline were as efficacious as the comparator, ertapenem, in patients with cIAI and were well tolerated. These results support the continued development of eravacycline for the treatment of serious infections, including those caused by drug-resistant Gram-negative pathogens. (This study has been registered at ClinicalTrials.gov under registration no. NCT01265784.).

Acute paediatric bite injuries treated on inpatient basis: a 10-year retrospective study and criteria for hospital admission.

The aim of this study was to evaluate the acute bite wounds in children treated on an inpatient basis over a 10-year period and the criteria for inpatient treatment. This study comprised all acute mammalian bite injuries in relation to all paediatric bite injuries seen at the Emergency Surgical Department (ESD). Inclusion criteria were: aged between 0-18 years; acute human or animal bite injuries (presenting for the first time); and inpatient treatment. Exclusion criteria were: bite wounds treated elsewhere and referred for complications; bites treated on an outpatient basis referred for complications; and all insect bites. Over 10 years, 12,948 children were seen at the ESD. There were 167 children (0.77%) with mammalian bite wounds. Twelve of them responded to the inclusion criteria. They presented 7.18% of all mammalian bite injuries and 0.09% of all paediatric emergency visits at the ESD. The average age was 3.82 ± 1.63 years (from 1.3-7 years). The time elapsed between the accident to the wound debridement was 118.64 ± 101.39 minutes. There were 10 dogs, one horse, and one rabbit bite. Surgical treatment comprised debridement, saline irrigation, and primary closure or reconstruction. All patients received antibiotics in the postoperative period. The average hospital stay was 5.92 ± 2.39 days. In one case a partial distal flap necrosis occurred. Animal bite injuries treated on an inpatient basis are predominantly dog bites in young children under 10 years of age, with deep, extended, and commonly multiple injuries. Only 7% of paediatric bite injuries require inpatient treatment.

Surgery in children with hydatid disease of the spleen.

BACKGROUND/PURPOSE: Hydatid disease of the spleen is a rare disease, and it occurs in 1% to 8% of all children with hydatid disease. That difference in frequency depends on the social and economic status of the patients and the country. The aim of our study is to reveal its diagnosis and treatment. METHODS: From 1985 to 2004, 152 children with hydatid disease have been operated on at the Surgical Department of General and Pediatric surgery at the Medical University in Stara Zagora and Medical University in Plovdiv, Bulgaria. Of the 152 children, 15 (9.87%) had spleen localization: 6 males and 9 females, aged 10 to 18 years. A solitary cyst in the spleen was found in 10 patients, 8 children had an isolated cyst only in the spleen, 7 with involvement of other organs (5 in the liver, 2 in liver and lungs). All spleen cysts were "silent." Abdominal sonography, computed tomography, and enzyme-linked immunosorbent assay tests proved the diagnosis. All children were operated on. RESULTS: A splenectomy was performed in 14 cases, and a cystectomy was possible in only 1 case. Patients with combined forms successfully underwent different variations of cystectomy: 6 omentoplasty, 5 capitonnages, and 4 invaginations. CONCLUSIONS: Splenic involvement of hydatid disease has no specific clinical manifestation, the diagnosis is late and often leads to splenectomy. Organ-preserving procedures are possible only in cases with early diagnosis. It has to be suspected in a patient with a splenic cyst and has to be confirmed by ultrasonography and/or computed tomography, magnetic resonance imaging, and immunologic tests. The early diagnosis is a good precondition for better results.