search
Back to results

Simplified Antibiotic Therapy for Sepsis in Young Infants (SATT)

Primary Purpose

Neonatal Sepsis, Sepsis, Infection

Status
Completed
Phase
Phase 3
Locations
Pakistan
Study Type
Interventional
Intervention
procaine penicillin and gentamicin
amoxicillin and gentamicin
procaine penicillin, gentamicin, amoxicillin
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonatal Sepsis focused on measuring infant, newborn, sepsis, infection, community

Eligibility Criteria

undefined - 59 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Inclusion Criteria

    • Infants 0-59 days old who are residents of catchment population of the study hospitals or clinics
    • One or more of the following five signs: severe chest in-drawing, axillary temperature >38.0C or <35.50 C, movement only when stimulated, and history of feeding problems (confirmed by poor suck on feeding assessment)
    • Family refuses recommended hospitalization or hospitalization otherwise not feasible
    • Informed consent by a legal guardian.
  • Exclusion Criteria:

Very severe infection/disease characterized by presence of any of the following signs (unconscious, convulsions, unable to feed, apnea, unable to cry, cyanosis, bulging fontanel, prolonged capillary refill, major congenital malformations, major bleeding, surgical conditions needing hospital referral, persistent vomiting defined as vomiting following three attempts to feed the baby within ½ hour)

  • Very low birth weight: weight <1500
  • Hospitalization for illness in the last two weeks
  • Previous inclusion in the study

Sites / Locations

  • Ali Akber Shah Goth

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

procaine penicillin and gentamicin

Amoxicillin and gentamicin

procaine penicillin, gentamicin, and amoxicillin

Arm Description

Procaine penicillin, 50,000 IU/kg by intramuscular injection plus gentamicin, 5 mg/kg intramuscular injection, both given once daily for 7 days

Oral amoxicillin (80-90 mg/kg) divided twice daily and intramuscular gentamicin, 5 mg/kg once daily, both given for 7 days

procaine penicillin, 50,000 IU/kg once daily intramuscular injection plus gentamicin 5 mg/kg once daily intramuscular injection for 2 days, followed by 5 days of oral amoxicillin, 80-90 mg/kg divided in two doses.

Outcomes

Primary Outcome Measures

Treatment failure

Secondary Outcome Measures

Full Information

First Posted
December 7, 2009
Last Updated
June 26, 2015
Sponsor
Aga Khan University
Collaborators
Save the Children, World Health Organization, London School of Hygiene and Tropical Medicine, Emory University
search

1. Study Identification

Unique Protocol Identification Number
NCT01027429
Brief Title
Simplified Antibiotic Therapy for Sepsis in Young Infants
Acronym
SATT
Official Title
Simplified Antibiotic Regimens for the Management of Sepsis in Young Infants in First-level Facilities: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University
Collaborators
Save the Children, World Health Organization, London School of Hygiene and Tropical Medicine, Emory University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This trial evaluates primary care clinic-based simplified antibiotic therapy options for young infants, 0-59 days old in high neonatal mortality settings in peri-urban Karachi where hospital referral is frequently refused by families.
Detailed Description
Primary Objective To evaluate if out-patient (clinic-based) therapy of young infants with possible serious bacterial infection with 7 days of intramuscular procaine penicillin and gentamicin (reference therapy) is equivalent to: (1) injectable gentamicin once daily and oral amoxicillin twice daily for seven days; (2) injectable penicillin and gentamicin once daily for two days followed by oral amoxicillin twice daily for five days; and Hypothesis The proportion of babies who fail therapy at (or before 7) days will be 10% in each group. A 5% or less difference in failure rates will be considered equivalent. Study Design This will be a randomized, three arm, open-label equivalence trial among young infants, 0-59 days of age who are diagnosed as having possible serious bacterial infection in one of the Karachi field clinics, and whose families refuse facilitated hospital referral, and the infants meet other specified inclusion criteria. Eligible young infants will be recruited from among those referred to the clinics by trained community health workers as having clinical signs predictive of possible serious illness during regular home visits in the surveillance area, or those presenting directly to the clinics from the areas under pregnancy and newborn surveillance. A diagnosis of possible sepsis will be made by clinicians if specified clinical criteria are met.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Sepsis, Sepsis, Infection
Keywords
infant, newborn, sepsis, infection, community

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2543 (Actual)

8. Arms, Groups, and Interventions

Arm Title
procaine penicillin and gentamicin
Arm Type
Active Comparator
Arm Description
Procaine penicillin, 50,000 IU/kg by intramuscular injection plus gentamicin, 5 mg/kg intramuscular injection, both given once daily for 7 days
Arm Title
Amoxicillin and gentamicin
Arm Type
Experimental
Arm Description
Oral amoxicillin (80-90 mg/kg) divided twice daily and intramuscular gentamicin, 5 mg/kg once daily, both given for 7 days
Arm Title
procaine penicillin, gentamicin, and amoxicillin
Arm Type
Experimental
Arm Description
procaine penicillin, 50,000 IU/kg once daily intramuscular injection plus gentamicin 5 mg/kg once daily intramuscular injection for 2 days, followed by 5 days of oral amoxicillin, 80-90 mg/kg divided in two doses.
Intervention Type
Drug
Intervention Name(s)
procaine penicillin and gentamicin
Intervention Description
procaine penicillin 50,000 units/kg by intramuscular injection once daily for 7 days; gentamicin, 5 mg/kg once daily by intramuscular injection for 7 days
Intervention Type
Drug
Intervention Name(s)
amoxicillin and gentamicin
Intervention Description
oral amoxicillin 80-90 mg/kg divided in two doses for 7 days intramuscular gentamicin, 5 mg/kg once daily for 7 days
Intervention Type
Drug
Intervention Name(s)
procaine penicillin, gentamicin, amoxicillin
Intervention Description
procaine penicillin, 50,000 IU/kg once daily intramuscular injection plus gentamicin 5 mg/kg once daily intramuscular injection for 2 days, followed by 5 days of oral amoxicillin, 80-90 mg/kg divided in two doses.
Primary Outcome Measure Information:
Title
Treatment failure
Time Frame
within 7 days of enrolment

10. Eligibility

Sex
All
Maximum Age & Unit of Time
59 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria Infants 0-59 days old who are residents of catchment population of the study hospitals or clinics One or more of the following five signs: severe chest in-drawing, axillary temperature >38.0C or <35.50 C, movement only when stimulated, and history of feeding problems (confirmed by poor suck on feeding assessment) Family refuses recommended hospitalization or hospitalization otherwise not feasible Informed consent by a legal guardian. Exclusion Criteria: Very severe infection/disease characterized by presence of any of the following signs (unconscious, convulsions, unable to feed, apnea, unable to cry, cyanosis, bulging fontanel, prolonged capillary refill, major congenital malformations, major bleeding, surgical conditions needing hospital referral, persistent vomiting defined as vomiting following three attempts to feed the baby within ½ hour) Very low birth weight: weight <1500 Hospitalization for illness in the last two weeks Previous inclusion in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiyam S Sunder, MBBS
Organizational Affiliation
The Aga Khan University
Official's Role
Study Director
Facility Information:
Facility Name
Ali Akber Shah Goth
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74800
Country
Pakistan

12. IPD Sharing Statement

Citations:
PubMed Identifier
32404437
Citation
Mir F, Pearce RE, Baig-Ansari N, Qazi S, Barrett JS, Abdel-Rahman S, Kearns G, Zaidi AK. Serum amoxicillin levels in young infants (0-59 days) with sepsis treated with oral amoxicillin. Arch Dis Child. 2020 Dec;105(12):1208-1214. doi: 10.1136/archdischild-2019-317342. Epub 2020 May 13.
Results Reference
derived
PubMed Identifier
27988146
Citation
Mir F, Nisar I, Tikmani SS, Baloch B, Shakoor S, Jehan F, Ahmed I, Cousens S, Zaidi AK. Simplified antibiotic regimens for treatment of clinical severe infection in the outpatient setting when referral is not possible for young infants in Pakistan (Simplified Antibiotic Therapy Trial [SATT]): a randomised, open-label, equivalence trial. Lancet Glob Health. 2017 Feb;5(2):e177-e185. doi: 10.1016/S2214-109X(16)30335-7. Epub 2016 Dec 15.
Results Reference
derived
PubMed Identifier
23945571
Citation
Zaidi AK, Tikmani SS, Sultana S, Baloch B, Kazi M, Rehman H, Karimi K, Jehan F, Ahmed I, Cousens S. Simplified antibiotic regimens for the management of clinically diagnosed severe infections in newborns and young infants in first-level facilities in Karachi, Pakistan: study design for an outpatient randomized controlled equivalence trial. Pediatr Infect Dis J. 2013 Sep;32 Suppl 1(Suppl 1 Innovative Treatment Regimens for Severe Infections in Young Infants):S19-25. doi: 10.1097/INF.0b013e31829ff7aa.
Results Reference
derived

Learn more about this trial

Simplified Antibiotic Therapy for Sepsis in Young Infants

We'll reach out to this number within 24 hrs