Treatment Outcome With Antibiotic Use and Its Resistance Pattern Among Patient With Neonatal Sepsis

February 14, 2023 updated by: Abd elrahman Ahmed Hussain Abd eltwaab, Assiut University
Determine Treatment outcome with antibiotic use and its resistance pattern among neonatal sepsis patients

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 (septicemia/meningitis) as the commonest cause of neonatal mortality, causing 23.4% 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, 56,524 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 ampicillin/amoxicillin/benzylpenicillin 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 70.7%, 54%, and 78.7% 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 (18.6%) 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, seizures,itteriness), 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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with neonatal sepsis

Description

Inclusion Criteria:

  • Newborn suspected with sepsis diagnosed on the basis of clinical signs and symptoms:
  • temperature instability
  • feeding problems,
  • convulsions,
  • lethargy
  • respiratory distress.
  • laboratory findings such as:
  • C-Reactive Protein (CRP)
  • complete blood count (CBC)
  • blood/urine cultures

Exclusion Criteria:

  • Respiratory distress syndrome
  • Congenital pneumonia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sepsis convelence
Time Frame: 24hours
It is difined by abcence of fever, jundice, respiratory failure and gastroentritis
24hours
Sepsis convelence
Time Frame: 1 week
It is difined by abcence of fever, jundice, respiratory failure and gastroentritis
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 31, 2023

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

August 22, 2022

First Submitted That Met QC Criteria

February 14, 2023

First Posted (Actual)

February 24, 2023

Study Record Updates

Last Update Posted (Actual)

February 24, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • neonatal sepsis treatment

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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