Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05742477
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-24
First Post:
2022-08-22
Brief Title:
Treatment Outcome With Antibiotic Use and Its Resistance Pattern Among Patient With Neonatal Sepsis
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Treatment Outcome With Antibiotic Use and Its Resistance Pattern Among Patient With Neonatal Sepsis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Determine Treatment outcome with antibiotic use and its resistance pattern among neonatal sepsis patients
Detailed Description:
Neonatal sepsis is a clinical syndrome characterized by systemic signs and symptoms of infection and is accompanied by bacteremia in the first month of life Early-onset sepsis EOS is defined as sepsis occurring in the first 72 h of life and that occurring beyond 72 h is defined as late-onset sepsis LOS As per World Health Organization WHO neonatal sepsis is the third most frequent etiology of neonatal mortality In the year 2013 a systematic analysis of global national and regional causes of child mortality found neonatal sepsis to be the leading cause of neonatal deaths in Europe The National Neonatal Perinatal Database network NNPD 2002-03 comprising 18 tertiary care neonatal units across Europe reported sepsis septicemiameningitis as the commonest cause of neonatal mortality causing 234 of all neonatal deaths The pattern of the bacterial pathogens responsible for neonatal sepsis has changed temporally and geographically There is a difference in the causative organisms for neonatal sepsis between developed and developing countries As per NNPD Klebsiella pneumonia and Staphylococcus aureus are the commonest causative organisms for EOS and LOS in Europe On the contrary data from developed countries shows that gram-positive organisms are the predominant causes of EOS as well as LOS The ability of bacteria to resist or to become tolerant to several structurally and functionally distinct drugs simultaneously is known as multidrug resistance Simpler definitions quote multidrug-resistant organisms MDROs are labeled as such because of their in-vitro resistance to more than one antimicrobial agent On the other hand definitions vary per specific organism It is estimated that in Europe 56524 neonatal deaths each year are attributed to isolates resistant to first-line antibiotics A recent point prevalence study - Antibiotic Resistance and Prescribing in European Children ARPEC was conducted in 226 hospitals 41 countries which This survey showed that most commonly used regimen for neonatal sepsis was a combination of ampicillinamoxicillinbenzylpenicillin Faculty of Medicine Institutional Review Board IRB Assiut Medical School Research Proposal Form 3 and aminoglycoside It further reported that 40 of pathogens isolated were resistant to first-line antibiotics prescribed by WHO Though this survey had a paucity of data from low- and middle-income countries LMICs it provided important insights into the emergence of antibiotic resistance Resistance to first-line antibiotics in different WHO regions Estimates of MDRO burden have also been reported from other countries In a systematic review of five countries in South Asia India Pakistan Sri Lanka Bangladesh and Nepal comprising 109 studies a high proportion of MDRO was reported The pooled estimated data from hospitals and communities showed that Klebsiella pneumonia E coli and Acinetobacter baumannii were multidrug resistant in 707 54 and 787 of isolates respectively A retrospective single-center study from Jordan evaluated 4 y data of 68 episodes of culture-positive neonatal sepsis Gram-negative organisms were the commonest and 69 of these were multidrug resistant In another cohort study from Taiwan conducted over 8 y 1106 episodes of culture-positive sepsis were reported Of these one-third were caused by gram-negative bacilli and 70 186 were multidrug resistant A meta-analysis of 71 studies reported from China showed that 50 of gram-negative organisms were resistant to third-generation cephalosporins Early signs of neonatal sepsis are Diminished spontaneous activity Less vigorous sucking Anorexia Apnea Bradycardia Temperature instability hypothermia or hyperthermia Fever is present in only 10 to 15 of neonates but when sustained eg 1 hour generally indicates infection Other symptoms and signs include respiratory distress neurologic findings eg seizuresitteriness jaundice especially occurring within the first 24 hours of life without Rh or ABO blood group incompatibility and with a higher than expected direct bilirubin concentration vomiting diarrhea and abdominal distention Periumbilical erythema discharge or bleeding without a hemorrhagic diathesis suggests omphalitis Faculty of Medicine Institutional Review Board IRB Assiut Medical School Research Proposal Form 4 infection prevents obliteration of the umbilical vessels Coma seizures opisthotonos or a bulging fontanelle suggests meningitis encephalitis or brain abscess
Decreased spontaneous movement of an extremity and swelling warmth erythema or tenderness over a joint indicates osteomyelitis or pyogenic arthritis
Decreased spontaneous movement of an extremity and swelling warmth erythema or tenderness over a joint indicates osteomyelitis or pyogenic arthritis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None