CLINICAL TRIALS PROFILE FOR PEDIAPRED

All Clinical Trials for Pediapred

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004228 ↗	Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma	Completed	National Cancer Institute (NCI)	Phase 3	2000-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for lymphoblastic lymphoma. PURPOSE: This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating children or adolescents with newly diagnosed stage III or stage IV lymphoblastic lymphoma.
NCT00004228 ↗	Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma	Completed	Children's Oncology Group	Phase 3	2000-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for lymphoblastic lymphoma. PURPOSE: This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating children or adolescents with newly diagnosed stage III or stage IV lymphoblastic lymphoma.
NCT00066469 ↗	Cyclophosphamide, Rituximab, and Either Prednisone or Methylprednisolone in Treating Patients With Lymphoproliferative Disease After Solid Organ Transplantation	Completed	National Cancer Institute (NCI)	Phase 2	2004-04-01	RATIONALE: Drugs used in chemotherapy such as cyclophosphamide, prednisone, and methylprednisolone use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining cyclophosphamide and either prednisone or methylprednisolone with rituximab may be effective in treating lymphoproliferative disease following organ transplantation. PURPOSE: Phase II trial to study the effectiveness of combining cyclophosphamide and either prednisone or methylprednisolone with rituximab in treating patients who have Epstein-Barr virus-positive lymphoproliferative disease following organ transplantation.
NCT00066469 ↗	Cyclophosphamide, Rituximab, and Either Prednisone or Methylprednisolone in Treating Patients With Lymphoproliferative Disease After Solid Organ Transplantation	Completed	Children's Oncology Group	Phase 2	2004-04-01	RATIONALE: Drugs used in chemotherapy such as cyclophosphamide, prednisone, and methylprednisolone use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining cyclophosphamide and either prednisone or methylprednisolone with rituximab may be effective in treating lymphoproliferative disease following organ transplantation. PURPOSE: Phase II trial to study the effectiveness of combining cyclophosphamide and either prednisone or methylprednisolone with rituximab in treating patients who have Epstein-Barr virus-positive lymphoproliferative disease following organ transplantation.
NCT00079105 ↗	A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years	Completed	Newcastle-upon-Tyne Hospitals NHS Trust	Phase 2	2004-01-01	RATIONALE: Drugs used in chemotherapy, such as vinblastine, cyclophosphamide, procarbazine, prednisolone, etoposide, mitoxantrone, and bleomycin, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer cells. PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating older patients with previously untreated Hodgkin's lymphoma.
NCT00796250 ↗	Efficacy of Infliximab in the Treatment of Patients Affected by Corticodependent Crohn's Disease (P02732)	Terminated	Merck Sharp & Dohme Corp.	Phase 3	2003-11-01	This is a double-blind, double-dummy, prednisolone-controlled, multi-center, randomized, parallel-group clinical study to evaluate the therapeutic efficacy of repeated infliximab infusions in order to maintain Crohn's disease remission at the end of the study.
NCT00967226 ↗	Propranolol Versus Prednisolone for Treatment of Symptomatic Hemangiomas	Terminated	Nancy Bauman	Phase 2	2009-07-01	Hemangiomas are relatively common lesions in infants. Most go away spontaneously after one year of life and do not need treatment. Others require treatment because they cause significant symptoms such as pain, or difficulty with breathing, eating or ambulating. Steroids have classically been used to treat hemangiomas and help to shrink them in 1/3 - 2/3 of patients. Unfortunately, steroids have many side effects in babies so physicians have sought other ways to treat them. Recently, the use of propranolol, a heart medication, was serendipitously found to reduce the size of hemangiomas. It appears to have many fewer side effects than steroids but it is not yet known if it works as well as steroids. This study seeks to compare the effect and the side effects of propranolol versus steroids for treating hemangiomas that cause symptoms in infants.

Clinical Trial Conditions for Pediapred

Condition Name

Condition Name for Pediapred
Intervention	Trials
Lymphoma	2
Canavan Disease	1
Crohn's Disease	1
Hemangioma of Infancy	1

Condition MeSH

Condition MeSH for Pediapred
Intervention	Trials
Lymphoma	2
Precursor Cell Lymphoblastic Leukemia-Lymphoma	1
Lymphoma, Non-Hodgkin	1
Canavan Disease	1

Clinical Trial Locations for Pediapred

Trials by Country

Trials by Country for Pediapred
Location	Trials
United States	81
Canada	15
Australia	8
United Kingdom	3
Puerto Rico	1

Trials by US State

Trials by US State for Pediapred
Location	Trials
Ohio	3
Washington	2
Indiana	2
Virginia	2
Illinois	2

Clinical Trial Progress for Pediapred

Clinical Trial Phase

Clinical Trial Phase for Pediapred
Clinical Trial Phase	Trials
Phase 3	2
Phase 2	3
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for Pediapred
Clinical Trial Phase	Trials
Completed	3
Terminated	2
Recruiting	1

Clinical Trial Sponsors for Pediapred

Sponsor Name

Sponsor Name for Pediapred
Sponsor	Trials
National Cancer Institute (NCI)	2
Children's Oncology Group	2
Newcastle-upon-Tyne Hospitals NHS Trust	1

Sponsor Type

Sponsor Type for Pediapred
Sponsor	Trials
Other	4
Industry	3
NIH	2

Transforming Pediatric Care: The PediCAP Trial, Market Analysis, and Projections for Pediatric Drugs

Introduction to PediCAP and Pediatric Drugs

The PediCAP trial, a groundbreaking clinical study, is at the forefront of transforming treatment options for children with severe community-acquired pneumonia. This initiative is part of a broader landscape of advancements in pediatric drugs, which are experiencing significant growth and innovation.

The PediCAP Trial: A Milestone in Pediatric Care

The PediCAP trial, funded by the European and Developing Countries Clinical Trials Partnership (EDCTP) and led by the MRC Clinical Trials Unit, has recently completed its recruitment phase, enrolling 1100 patients across several countries including Mozambique, South Africa, Uganda, Zambia, and Zimbabwe. This trial focuses on determining the optimal drug, dose, and duration of oral step-down antibiotics for children aged between 2 months and 6 years admitted to hospital with severe community-acquired pneumonia[1].

Key Objectives of PediCAP

• Optimal Treatment: Evaluate the safety and efficacy of an early step-down from intravenous to oral antibiotics.
• Drug Formulations: Compare different durations of oral amoxicillin to co-amoxiclav.
• Child-Friendly Medications: Utilize novel paediatric dispersible tablet formulations, such as those donated by Sandoz, to enhance compliance and outcomes[1].

Market Analysis of Pediatric Drugs

The pediatric drugs market is experiencing robust growth, driven by increasing health issues among children and the need for more effective and child-friendly treatments.

Market Size and Growth

• The global pediatric drugs market was valued at USD 28.8 billion in 2023 and is projected to reach USD 95.4 billion by 2033, growing at a CAGR of 12.7% during the forecast period from 2024 to 2033[2].
• Another estimate suggests the market will hit around USD 460.12 billion by 2034, expanding at a CAGR of 12.20% from 2024 to 2034[5].

Dominant Segments

• Respiratory Disorder Drugs: These dominate the market with a 39.4% market share in 2023, reflecting the high prevalence of respiratory infections such as pneumonia[2].
• Oral Route of Administration: Oral medications account for 48.7% of the market, highlighting the preference for easy-to-administer formulations[2].
• Distribution Channels: Hospital pharmacies lead the market, capturing a significant share of 52.7% in 2023[2].

Regional Analysis

• North America: This region dominates the market with a 34.9% share in 2023, followed by other regions such as Europe, Asia-Pacific, and the Middle East & Africa[2][5].

Innovative Treatments and Regulatory Approvals

New Formulations and Therapies

• There is a surge in the development of innovative pediatric treatments, including new formulations of existing drugs, gene therapies, and child-friendly medications. The inclusion of dispersible tablet formulations, such as those used in the PediCAP trial, in the WHO’s Essential Medicines List for Children underscores this trend[1][2].

Regulatory Support

• Regulatory bodies are supportive of these innovations, with a focus on ensuring safety and efficacy. For instance, the donation of novel paediatric dispersible tablet formulations by Sandoz for the PediCAP trial highlights industry and regulatory collaboration[1].

Clinical Trials Landscape

Global Trends

• The global clinical trials market is growing significantly, with a projected size of $106.78 billion by 2032, at a CAGR of 7.1% during the forecast period. This growth is fueled by the increasing need to treat chronic diseases and the rising number of registered trials globally[3].

Challenges and Successes

• The PediCAP trial’s successful recruitment despite the challenges posed by the COVID-19 pandemic is a testament to the dedication and effort of the teams involved. Such successes are crucial for advancing treatment options in pediatric care[1].

Health Economic and Pharmacokinetic Analyses

Economic Impact

• The PediCAP trial includes planned health economic analyses to assess the cost-effectiveness of the treatment options being evaluated. This is critical for ensuring that any new treatment recommendations are not only effective but also economically viable[1].

Pharmacokinetic Studies

• Pharmacokinetic analyses are also integral to the trial, helping to determine the optimal dosing and duration of antibiotics for children. These studies are essential for ensuring the safety and efficacy of the treatments[1].

Quotes from Industry Experts

• Carlo Giaquinto, President of Penta: "Pneumonia poses a serious health threat to children but I believe that through the analysis of the PediCAP-A trial results, meaningful conclusions will be drawn that could advance treatment options for children with severe and very severe pneumonia."[1]
• Professor Mike Sharland, Chief Investigator of PediCAP: "The full recruitment to the PediCAP-A trial through the challenges of Covid-19 has been a remarkable success, reflecting a huge effort of all the teams involved."[1]

Illustrative Statistics

• UNICEF Report: Approximately 5.2 million children under the age of five were anticipated to die by 2020, equating to 13,900 children dying every day[2].
• Market Growth: The pediatric drugs market is expected to grow from USD 28.8 billion in 2023 to USD 95.4 billion by 2033, at a CAGR of 12.7%[2].

Key Takeaways

• The PediCAP trial is a significant step towards improving treatment options for children with severe community-acquired pneumonia.
• The pediatric drugs market is experiencing rapid growth driven by the need for effective and child-friendly treatments.
• Innovations in drug formulations and regulatory approvals are crucial for advancing pediatric care.
• Clinical trials, such as PediCAP, are vital for determining the safety, efficacy, and cost-effectiveness of new treatments.

FAQs

What is the PediCAP trial?

The PediCAP trial is a clinical study investigating the optimal drug, dose, and duration of oral step-down antibiotics for children with severe community-acquired pneumonia.

What is the current status of the PediCAP trial?

The PediCAP trial has completed its recruitment phase, enrolling 1100 patients across several countries.

How big is the pediatric drugs market?

The global pediatric drugs market was valued at USD 28.8 billion in 2023 and is projected to reach USD 95.4 billion by 2033.

What are the dominant segments in the pediatric drugs market?

Respiratory disorder drugs and oral route of administration dominate the market, with hospital pharmacies being the leading distribution channel.

What are the key innovations in pediatric drugs?

New formulations of existing drugs, gene therapies, and child-friendly medications, such as dispersible tablet formulations, are key innovations in the field.

How does the PediCAP trial contribute to pediatric care?

The PediCAP trial aims to establish more convenient and potentially equally effective alternatives to current WHO intravenous treatment recommendations for severe pneumonia in children.