AzTrials
AzTrials

Neonatal SepsisPhase 3SATTNCT01027429

Simplified Antibiotic Therapy for Sepsis in Young Infants

A Phase 3 study testing procaine penicillin and gentamicin, amoxicillin and gentamicin and procaine penicillin, gentamicin, amoxicillin in people with Neonatal Sepsis and Sepsis, run by Aga Khan University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 59 days
Conditions the study is for
Neonatal Sepsis, Sepsis, Infection
What is being tested?
procaine penicillin and gentamicin, amoxicillin and gentamicin and procaine penicillin, gentamicin, amoxicillin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,543 participants
Where
1 sitePakistan
Study dates
Dec 2009to Dec 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 59 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Ali Akber Shah Goth

    Karachi, Sindh, 74800

Other trials in Pakistan

About this study

Official title: Simplified Antibiotic Regimens for the Management of Sepsis in Young Infants in First-level Facilities: Randomized Controlled Trial

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.

Read the 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.

Being tested
procaine penicillin and gentamicin, amoxicillin and gentamicin, procaine penicillin, gentamicin, amoxicillin
Keywords
infant, newborn, sepsis, infection, community
Medical subject headings
Neonatal Sepsis, Sepsis, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • procaine penicillin and gentamicinDrug

    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

  • amoxicillin and gentamicinDrug

    oral amoxicillin 80-90 mg/kg divided in two doses for 7 days intramuscular gentamicin, 5 mg/kg once daily for 7 days

  • procaine penicillin, gentamicin, amoxicillinDrug

    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.

Study groups in NCT01027429
Study groupRoleWhat they receive
procaine penicillin and gentamicinActive comparatorProcaine penicillin, 50,000 IU/kg by intramuscular injection plus gentamicin, 5 mg/kg intramuscular injection, both given once daily for 7 days
Receives: Drug: procaine penicillin and gentamicin; Drug: procaine penicillin, gentamicin, amoxicillin
Amoxicillin and gentamicinExperimentalOral amoxicillin (80-90 mg/kg) divided twice daily and intramuscular gentamicin, 5 mg/kg once daily, both given for 7 days
Receives: Drug: amoxicillin and gentamicin; Drug: procaine penicillin, gentamicin, amoxicillin
procaine penicillin, gentamicin, and amoxicillinExperimentalprocaine 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.
Receives: Drug: procaine penicillin, gentamicin, amoxicillin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment failure

    Measured: within 7 days of enrolment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,543 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01027429
Sponsor's protocol ID
SC134GL50124
Acronym
SATT
Status last verified
Jun 2015
First submitted
7 Dec 2009
Last updated
29 Jun 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Longombe AL, Ayede AI, Marete I, Mir F, Ejembi CL, Shahidullah M, Adejuyigbe EA, Wammanda RD, Tshefu A, Esamai F, Zaidi AK, Baqui AH, Cousens S. Oral amoxicillin plus gentamicin regimens may be superior to the procaine-penicillin plus gentamicin regimens for treatment of young infants with possible serious bacterial infection when referral is not feasible: Pooled analysis from three trials in Africa and Asia. J Glob Health. 2022 Nov 21;12:04084. doi: 10.7189/jogh.12.04084.

    PubMed 36403158

  • 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.

    PubMed 32404437

  • 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.

    PubMed 27988146

  • 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.

    PubMed 23945571

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing procaine penicillin and gentamicin, amoxicillin and gentamicin and procaine penicillin, gentamicin, amoxicillin in people with Neonatal Sepsis and Sepsis, run by Aga Khan University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment failure (time frame: within 7 days of enrolment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01027429, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2015.

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