Health Condition 1: A499- Bacterial infection, unspecified Health Condition 2: D50-D89- Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism
Conditions
Interventions
Intervention1: Outpatient Parenteral Antimicrobial Therapy: Prospective implementation of structured outpatient parenteral antimicrobial therapy in clinically stable adult patients with haematological
Sponsors
Dr Nusrat Shafiq
Eligibility
Inclusion criteria
Inclusion criteria: Hematological disorders or post hematopoietic stem cell transplant patients with proven or suspected infection requiring single agent intravenous antimicrobial therapy for cat least 3 days Oral antimicrobial therapy not appropriate. Clinically stable and eligible for outpatient care First intravenous dose administered in hospital Written informed consent provided Caregiver able to read and speak Hindi or Panjabi and trained in sterile drug administration. Fixed residence within one hour travel; for meropenem within five kilometers. Telephone, running water, electricity, and refrigeration required.
Exclusion criteria
Exclusion criteria: Known hypersensitivity to either of the antimicrobial agents Pregnant or lactating females Clinically unstable patients who are not suitable for OPAT therapy Severe comorbidities contraindicating outpatient management Patient requiring more than one parenteral antimicrobial agent Caregiver is not able to perform the sterile drug administration technique
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients successfully completing OPAT without unplanned readmissionTimepoint: At completion of OPAT therapy, approximately 3-14 days after initiation of OPAT | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving clinical cure, improvement, or clinical failureTimepoint: At completion of OPAT therapy, approximately 3 to 14 days after initiation of OPAT;Requirement of unplanned hospital readmission due to infection relapse or OPAT related complicationTimepoint: assessed within 7 days of OPAT completion which will be approximately 3 to 14 days after initiation of OPAT;Incidence of adverse events, including drug related & vascular access related complicationsTimepoint: from initiation of OPAT until end of therapy which will be approximately 3 to 14 days after initiation of OPAT;A cost analysis comparing OPAT, both gravity drip & elastomeric pump with standard inpatient antimicrobial therapy will be performed using prospectively collected direct medical cost dataTimepoint: Total cost per patient will be calculated at the end of therapy which will be approximately 3 to 14 days after initiation of OPAT, assuming equivalent duration of treatment in both groups.;Patient satisfaction & acceptability of OPAT will be assessed using a structured questionnaire covering domains of training & education, caregiver experience with drug administration, patient comfort with infusion method, follow up support, & overall satisfactionTimepoint: At completion of OPAT therapy, approximately 3 to 14 days after initiation of OPAT;Steady-state plasma concentrations of piperacillin-tazobactam, cefoperazone-sulbactam, meropenem, & vancomycin will be measured using validated analytical methods (HPLC/LC-MS/Immunoassay) to determine achievement of therapeutic levels during OPAT administered via gravity drip or elastomeric pump.Timepoint: At the first visit after OPAT initiation which will be After 48 hours And At End of Therapy which will be approximately 3 to 14 days after initiation of OPAT;Physical & chemical stability of piperacillin tazobactam, meropenem, cefoperazone sulbactam, & vancomycin prepared in elastomeric pumps & gravity infusion bags will be evaluated under | — |
Countries
India
Contacts
Public ContactDr Nusrat Shafiq
Postgraduate Institute of Medical Education and Research
Outcome results
None listed