Oxygen Optimization Therapy through BCPAP for management of childhood pneumonia in general hospitals of LMICs

Informazioni relative al progetto

OPT-bCPAP

ID dell’accordo di sovvenzione: 101145797

DOI

10.3030/101145797

Data della firma CE 29 Maggio 2024

Data di avvio 1 Giugno 2024

Data di completamento 31 Maggio 2029

Finanziato da

• Health

Costo totale

€ 4 641 691,25

Contributo UE

€ 4 641 691,25

Coordinato da

UNIVERSITY OF CAPE TOWN LUNG INSTITUTE PTY LTD*
South Africa

Periodic Reporting for period 1 - OPT-bCPAP (Oxygen Optimization Therapy through BCPAP for management of childhood pneumonia in general hospitals of LMICs)

Periodo di rendicontazione: 2024-06-01 al 2025-11-30

Sintesi del contesto e degli obiettivi generali del progetto

The project “Optimizing Severe Pneumonia Management in Children Through Scale up of Bubble continuous positive airway pressure (bCPAP) technology in Low Resource settings (OPT-bCPAP) is a 5- year project aiming to improve the treatment of severe pneumonia, through implementing and evaluating contextually appropriate bCPAP oxygen therapy, exploring severe pneumonia aetiology, and antibiotic therapy across hospitals in three low-resource countries Ethiopia, Nigeria, and Malawi.

To achieve the project’s aim, nine objectives were set out:
1. To evaluate barriers and facilitators and develop contextually relevant implementation strategies for the implementation of bCPAP
2. To evaluate the implementation of bCPAP, exploring how the intervention worked – or didn’t, in what contexts and for whom, and identify strategies that could optimize implementation of bCPAP
3. To determine the cost-effectiveness of bCPAP for preventing treatment failure, mortality and reducing hospitalization days for children with severe pneumonia
4. To determine the burden of RSV among children admitted to hospital with severe pneumonia
5. To identify factors associated with antimicrobial use and adherence to treatment guidelines
6. To assess health care seeking behaviour of mothers and care givers
7. To determine the impact of antimicrobial choice, duration, guideline concordance and appropriateness on treatment outcome and mortality
8. To determine the impact of antibiotic treatment on the nasopharyngeal microbiome
9. To evaluate the pharmacokinetics of first line antibiotics used for the treatment of severe pneumonia in children.

To achieve these objectives, we constructed 11 Work Packages.

1. Timely execution of project Milestones and Deliverables through Consortium and Financial Management (WP1)
2. Establishment of a Data Management Plan (WP2)
3. To outline the implementation of bCPAP through the creation of a standardised protocol, standard operating procedures (SOPs), guidelines for implementation, guidelines for training, evaluation of training, and data collection tools (WP3).
4. Engage with stakeholders through workshops and disseminate workshops proceedings prior to the start of the project (WP4).
5. Conduct cost-effectiveness analysis during the baseline and implementation phases of the project (WP5)
6. Capacity building of students, staff in implementation science and pneumonia diagnosis and management (WP6)
7. Assessment of behavioural factors associated with treatment failure and mortality (WP7)
8. Respiratory Syncytial Virus and Antimicrobial Resistance Baseline Determination (WP8)
9. Pharmacokinetics/Pharmacodynamics Analysis (WP9)
10. Dissemination, Exploitation, and Communication (WP10)
11. Establishment of an Independent Ethical Review Board (WP11)

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

During the initial 18 month period, we drafted and executed the Consortium Agreement and set up the Coordinating Centre at UCTLI (WP1) as well as set up an Independent Ethical Advisory Board (WP11). The site set up involved the creation of a Steering Commitee and the establishment of a Project Management Plan and Data Sharing Agreement process that was agreed upon in early 2026 by the SC. Overall management includes ongoing bi-weekkly consortium meetings with annual in-person meetings in project implementation countries: Ethiopia in August 2024 for the kick-off meeting, and Malawi in August 2025. A meeting is planned for mid-August 2026 in Nigeria, the third implementation country with a representative from each of the beneficiaries to be present.

During the creations of a standardised protocol, timelines were fine-tuned to include a formative phase of the project, enabling sites to research optimal locations for the planned baseline and implementation phases. This formative phase, which is ongoing, has involved field visits to proposed sites and evaluation of their current infrastructure and staffing capacity according to a pre-designed set of rating criteria.
A set of standard operating procedures (SOPs), Data Management Plan (D18), guidelines for pneumonia diagnosis training, implementation, and pneumonia training evaluation, and data collection tools have also been established (WP3). Refining of analysis tools will take place throughout the project and following the completion of data collection in late 2028.

Other notable work achieved includes the creation of a stakeholder engagement plan (D9) and engagement with stakeholders through a series of workshops (WP4), identification of PhD candidates for expanding knowledge of implementation science and pneumonia management (WP6) and the execution of a childhood pneumonia management training manual.

A childhood pneumonia management training manual has been drafted as part of WP6. The creation of the manual has involved input from project clinicians and the Independent Advisory Board content expert. This training manual is being utilised for the training of the clinical staff at the selected hospitals prior to the commencement of the baseline data collection phase.
In early 2026, in depth interviews began at implementation sites on the assessment of health care seeking behaviours of mothers and other caregivers of children admitted with severe pneumonia (WP7). In-depth interviews are conducted and coded using a cross-site coding methodology to ensure results can be compared across settings.

Preparation work for the Respiratory Syncytial Virus (RSV) and Antimicrobial Resistance Baseline Determination to determine the burden of both RSV and antimicrobial resistance (WP8) has begun with the identification of laboratories, purchasing of consumables, and creation of a draft data collection tool that will be ratified in September/October 2026. Data will be collected as part of the baseline phase of the project in all three implementation countries.

Work package 9, set out to determine the PK and PD of first line and second line antibiotics used in the management of severe childhood pnemonia. Following ethical review of the activities to take place in association with thie WP, the consortium has had to redesign this section of the project. Concerns from the Malawian and Independent ethics board committees arose from the proposed repeated blood collection required. The frequency and volume of blood initially proposed was deemed unethical, and in an effort to achieve the aims of WP 9 without compromising participant safety, the frequency of invasive blood draws was adjusted through the adoption of an adult sub-study.
As a result, plasma would only be collected from a group of health adult-volunteers through a sub-study and determination of the antibiotic concentrations would be determined against their Dried Blood Spot (DBS) samples to determine concentration ratios between the two samples in adults. Samples collected from children would therefore be limited to low-volume DBS samples with the ratio extrapolated from the adults.

Final achievements include the completion of a full Dissemination Plan (D22) and Publication Guideline (D16).

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

The study is in its formative phase and no results have been generated yet.