NCT05051163

Brief Summary

This study to investigate whether empiric use of an antibiotic with greater antimicrobial sensitivity (ceftriaxone) than standard-of-care (ampicillin plus gentamicin) will reduce mortality among HIV-infected/HEU children admitted to Mwanamugimu Nutrition Unit, Mulago Hospital, Kampala, Uganda.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2021

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 14, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 21, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2024

Completed
Last Updated

September 30, 2021

Status Verified

September 1, 2021

Enrollment Period

3 years

First QC Date

August 6, 2021

Last Update Submit

September 24, 2021

Conditions

HIV-1-infectionMalnutrition, Child

Outcome Measures

Primary Outcomes (1)

  • In hospital mortality

    Cumulative incidence

    4 weeks

Secondary Outcomes (9)

  • Length of hospitalization

    90 days

  • Weight-for-height z-score

    90 days

  • Weight-for-age z-score

    90 days

  • Height-for-age z-score

    90 days

  • Pattern and antimicrobial sensitivity of pathogens

    7 days

  • +4 more secondary outcomes

Study Arms (2)

Ceftriaxone

EXPERIMENTAL

Ceftriaxone will be administered intravenously at a dose of 50 - 75mg/kg once daily

Drug: Ceftriaxone Sodium

Ampicillin and Gentamicin

ACTIVE COMPARATOR

1. Ampicillin will be administered intravenously at a dose of 50mg/kg 6hourly 2. Gentamicin will be administered intravenously at a dose 5mg/kg once daily

Drug: AmpicillinDrug: Gentamicin

Interventions

Ceftriaxone SodiumDRUG

7 days of once daily dosing

Also known as: ZEFONE-1000
Ceftriaxone
AmpicillinDRUG

7 days of 6 hourly dosing

Also known as: AMPIMAX-500
Ampicillin and Gentamicin
GentamicinDRUG

7 days of once daily dosing

Also known as: GENTAMICIN INJECTION
Ampicillin and Gentamicin

Eligibility Criteria

Age1 Month - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • HIV-infected children aged 1 to 59 months admitted at Mwanamugimu Nutrition Unit with severe acute malnutrition
  • HIV exposed but uninfected children aged 1 to 59 months admitted at Mwanamugimu Nutrition Unit with severe acute malnutrition
  • For prevalence of HIV-infection sub-study, children presenting with severe acute malnutrition on admission at Mwanamugimu Nutrition Unit.
  • For PK sub-study, the child should have been on antiretroviral therapy for at least 2weeks and should have been in hospital for at least 2weeks.

You may not qualify if:

  • For PK sub-study; a child with documented poor adherence to antiretroviral therapy.
  • For PK sub-study; a child known to have vomited the drug on the sampling day.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Makerere University College of Health Sciences

Kampala, Central Region, 7072, Uganda

RECRUITING

Related Publications (1)

  • Musiime V, Kiggwe A, Beinomugisha J, Kakooza L, Thembo-Mwesige J, Nkinzi S, Naguti E, Atuhaire L, Segawa I, Ssengooba W, Mukonzo JK, Babirekere-Iriso E, Musoke P. Strategies to Reduce Mortality Among Children Living With HIV and Children Exposed to HIV but Are Uninfected, Admitted With Severe Acute Malnutrition at Mulago Hospital, Uganda (REDMOTHIV): A Mixed Methods Study. Front Pediatr. 2022 Jun 24;10:880355. doi: 10.3389/fped.2022.880355. eCollection 2022.

    PMID: 35813373DERIVED

MeSH Terms

Conditions

Child Nutrition Disorders

Interventions

CeftriaxoneAmpicillinGentamicins

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CefotaximeCephacetrileCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPenicillin GPenicillinsAminoglycosidesGlycosidesCarbohydrates

Central Study Contacts

Victor Musiime, PhD

CONTACT

+256772401749musiimev@yahoo.co.uk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Open label parallel group randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 6, 2021

First Posted

September 21, 2021

Study Start

June 14, 2021

Primary Completion

June 14, 2024

Study Completion

June 14, 2024

Last Updated

September 30, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

When results are required as part of a meta-analysis or as secondary data.

Shared Documents
STUDY PROTOCOL
Time Frame
1 year after end of data collection
Access Criteria
On request to Principal Investigator

Locations

UG(1)