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POLARITY

Point-of-Care Diagnostics for Guiding Therapy in Severe Acute Respiratory Infections for Children 60 days to 15 years of age in rural Ghana

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202512697299437
Enrollment
300
Registered
2025-12-05
Start date
2025-11-15
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Paediatrics

Interventions

Point of care diagnostics package

Sponsors

Bernhard Nocht Institute for Tropical Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Consent/Assent to participate in the study. 2. 60 days to 15 years of age. 3. Admitted to hospital as per local clinician criteria under the diagnosis of Severe Acute Respiratory infection defined as: new onset ( 50 breaths/minute in children aged 2-11 months ii. > 40 breaths/min in children aged 12-60 months iii. > 30 breaths/min in children aged 5 - 12 years iv. > 20 breaths/min in adolescents aged 12 - 15 years

Exclusion criteria

Exclusion criteria: 1. Known Tuberculosis or a patient highly suspected at presentation 2. Aspiration Pneumonia (or highly suspected at presentation) 3. Hospital-acquired Pneumonia (48 hours or more after hospital admission) in the last 7 days prior to screening 4. Known lung abscess, cavern or empyema 5. Clinical suspicion of non-respiratory, primary source of infections with exception of malaria. 6. Critically ill patient when presenting to ED with signs of respiratory failure and indication for a. resuscitation b. current vasopressor use c. mechanical ventilation via endotracheal tube 7. Severe Immunosuppression a. Known Neutropenia (<1 leucocyte/mL or < 0.5 neutrophil/mL) b. Known HIV/AIDS with WHO clinical stage 4 disease or with CD4 < 200 cells/ml in children =6 years; < 500 cells/ml in children 1-5 years; < 750 cells/ml in children<12 months c. Severe malnutrition (kwashiorkor, marasmus (weight for height <-3 SD), severe stunting (height for age <-3SD)) 8. Known Malignancy a. Metastatic cancer 9. Immunosuppressive therapy a. Immunosuppressive drugs within the previous 30 days, including anti-cancer chemotherapy and anti-rejection drugs for organ/bone marrow transplant b. Systemic corticosteroids therapy 10. Chronic dialysis 11. Surgery in the past 7 days (excluding minor surgery such as skin biopsy) 12. Other respiratory conditions a. Tracheostomy b. Diffuse bronchiectasis, cystic fibrosis.

Design outcomes

Primary

MeasureTime frame
The sensitivity and specificity of a point-of-care diagnostic package in distinguishing viral from bacterial Severe Acute Respiratory Infection (SARI) amongst children aged 60 days to 15 years in a malaria-endemic setting in Africa.

Secondary

MeasureTime frame
Effect of malaria co-infection on the diagnostic performance of inflammatory biomarkers (e.g., C-reactive protein, procalcitonin);The impact of an antimicrobial stewardship (AMS) training program on antimicrobial use (AMU) and prescription practices at the study site;Exploratory. Characterizing the temporal pattens of inflammatory biomarkers throughout hospitalization and explore their potential to inform AMS actions;Exploratory. The frequency of Mycoplasma pneumoniae (Mp) causing SARI admission amongst children aged 60 days to 15 years at the St. Francis Xavier Hospital (SFXH) in Assin Foso, Ghana

Countries

Ghana

Contacts

Public ContactRobin Kobbe

CoPrincipal Investigator BNITM

robin.kobbe@bnitm.de+49285380244

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026