Effect of caspofungin with trimethoprim-sulfamethoxazole in the treatment of Pneumocystis pneumonia in HIV patients

Comparative evaluation of the efficacy and safety of a combination regimen of trimethoprim-sulfamethoxazole and caspofungin versus trimethoprim-sulfamethoxazole monotherapy in the management of Pneumocystis pneumonia among HIV-infected patients

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180610040037N6

Enrollment

Registered

2025-07-25

Start date

2025-07-22

Completion date

Unknown

Last updated

2025-08-19

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

Conditions

Pneumocystis pneumonia (PCP) in HIV-infected patients. HIV disease resulting in Pneumocystis jirovecii pneumonia

Interventions

Intervention 1: Intervention group: Patients will receive trimethoprim-sulfamethoxazole (TMP 15–20 mg/kg/day and SMX 75–100 mg/kg/day) plus caspofungin (70 mg on day 1 followed by 50 mg daily for 21 d

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Confirmed HIV infection Age = 18 years Clinical or microbiological suspicion of PCP Written informed consent

Exclusion criteria

Exclusion criteria: Intolerance or intolerance to trimethoprim or its components History of immune-mediated drug-induced thrombocytopenia caused by sulfonamides or trimethoprim Hypersensitivity to caspofungin or any component of the drug formulation Severe hepatic/renal impairment contraindicating drug use Other confirmed diagnoses (non-PCP pneumonia, etc.) Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
All-cause mortality at day 30 after initiation of treatment. Timepoint: Day 30 after treatment initiation. Method of measurement: Clinical follow-up and review of patient records to confirm survival status.	—

Secondary

Measure	Time frame
Clinical response after completion of treatment. Timepoint: Day 21. Method of measurement: Assessment of symptom improvement and oxygenation (PaO2).;Treatment failure during the first 7 days. Timepoint: Day 7. Method of measurement: Worsening clinical status, persistent fever, or hypoxia.;Incidence of adverse drug reactions. Timepoint: During treatment (up to day 21). Method of measurement: Clinical evaluation and lab tests (CBC, LFT, etc.).;Comparison of time to clinical response between the intervention and control. Timepoint: Daily assessment during the 21-day treatment period. Method of measurement: Clinical observation of symptom relief and improvement in oxygen saturation (SpO2/PaO2).	—

Measure

Time frame

Clinical response after completion of treatment. Timepoint: Day 21. Method of measurement: Assessment of symptom improvement and oxygenation (PaO2).;Treatment failure during the first 7 days. Timepoint: Day 7. Method of measurement: Worsening clinical status, persistent fever, or hypoxia.;Incidence of adverse drug reactions. Timepoint: During treatment (up to day 21). Method of measurement: Clinical evaluation and lab tests (CBC, LFT, etc.).;Comparison of time to clinical response between the intervention and control. Timepoint: Daily assessment during the 21-day treatment period. Method of measurement: Clinical observation of symptom relief and improvement in oxygen saturation (SpO2/PaO2).

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Seyed Ali Dehghan Manshadi

Tehran University of Medical Sciences

a_dehghanm@sina.tums.ac.ir+98 21 6692 4001

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026