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Empirical Treatment Against Cytomegalovirus and Tuberculosis in HIV-infected Infants With Severe Pneumonia (EMPIRICAL)

Primary Purpose

Pneumonia, HIV/AIDS, Tuberculosis

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Valganciclovir Oral Solution [Valcyte]
Tuberculostatic Agents
Sponsored by
Hospital Universitario 12 de Octubre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia

Eligibility Criteria

28 Days - 365 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 28 days to 365 days of age
  2. Pneumonia defined as chest indrawing or fast breathing for age, for infants 28 to 60 days of age ≥60 breaths per minute and for infants 61 to 365 days of age, ≥50 breaths per minute.
  3. Current hospitalization due to pneumonia with criteria for parenteral antibiotics (1 or more criteria)

    1. Chest indrawing with HIV infection
    2. No improvement with oral treatment.
    3. One or more danger signs according to WHO 5,44,45

      • Central cyanosis or saturation of O2 <90%
      • Severe respiratory distress, e.g. grunting or very severe chest indrawing
      • Signs of pneumonia with a general danger sign:
      • Unable to drink or breastfeed
      • Persisting vomiting
      • Convulsions in the last 24 hours
      • Lethargic or unconscious
      • Stridor while calm
      • Severe malnutrition
  4. HIV-confirmed infection (with at least one molecular method: DNA polymerase chain reaction (PCR) or RNA PCR/viral load).
  5. Informed consent obtained

Exclusion Criteria:

  1. Clinical TB (pulmonary or extrapulmonary) diagnosis, defined as the necessity of TB-T prescribed by a physician, at the moment of randomization
  2. Known bacteriologically confirmed TB case (at least one biological specimen positive by culture or Xpert MTB/RIF) at the moment of randomization
  3. Patient previously treated for TB or currently on treatment for TB
  4. Documented evidence of close TB exposure (household contact of a patient with documented TB during the lifetime of the child, or currently receiving TB-T)
  5. Pure wheezers defined as a clear clinical improvement after a bronchodilator test (give a challenge of rapid-acting inhaled bronchodilator for up to three times 15-20 minutes apart. Count the breaths and look for chest indrawing again, and then re-classify)
  6. Active malignancies
  7. Systemic immunosuppressive medications. Steroids will be considered to be immunosuppressing only if >2 mg/kg of prednisone or equivalent during >15 days
  8. Evidence of condition other than HIV and pneumonia which precludes, to the judgment of the clinical researcher, enrollment in this trial due to risk for the patient. In case of doubt, the Trial Management Team will be contacted to assess eligibility
  9. Less than 2.5 kg of weight
  10. Hb <6 g/dL in the screening blood test or in a test done in the last 48 hours. Transfusion is permitted to achieve >6 g/dL if the patient's state allows it. In case a transfusion is administered, the patient can be enrolled
  11. Neutropenia <500 /mm3 in the screening blood test or in a test done in the last 48 hours. Repeating the test is allowed to check eligibility

Sites / Locations

  • Programme PACCI. Centre Hospitalier Cocody.Recruiting
  • Université de Bourdeaux
  • INSERM
  • PENTA Foundation
  • Malawi Liverpool Welcome Trust. Queen Elizabeth Central Hospital College of MedicineRecruiting
  • Cemtro de Investigaçao em Saúde da ManhiçaRecruiting
  • Hospital Central MaputoRecruiting
  • Stichting Katholieke Universiteit Radboudumc
  • Fundación para la Investigación Biomédica del Hospital 12 de Octubre
  • Makerere University - Mulago HospitalRecruiting
  • University of Lincoln
  • Lusaka Teaching HospitalRecruiting
  • University of Zimbabwe Clinical Research CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Standard of Care (SoC)

Valganciclovir plus SoC

Tuberculosis Treatment plus SoC

Tuberculosis Treatment plus Valganciclovir plus SoC

Arm Description

Standard treatment for severe pneumonia and pneumonia in HIV-infected infants: Ceftriaxone 80 mg/k/day or Ampicillin plus Gentamicin ampicillin 50 mg/kg, or benzylpenicillin 50,000 unit/kg im/iv every six hours plus Gentamicin 7.5 mg/kg/im or iv once a day Cotrimoxazole trimethoprim (TMP) 8mg/kg/dose + sulfamethoxazole (SMX) 40mg/kg/dose three times daily Prednisolone 2mg/kg during 7 days, plus 1mg/kg other 7 days, plus 0.5 mg/kg for 7 days

Treatment for cytomegalovirus (CMV) Valganciclovir (powder for suspension, 50 mg/mL) oral, 16 mg/kg/12 hours for 15 days, and Standard or Care as described in Control Group

Treatment for tuberculosis Fixed-dose dispersible tablet of rifampicin, isoniazid, pyrazinamide (75/50/150 mg) Fixed-dose dispersible tablet of rifampicin/isoniazid (75/50 mg) Ethambutol 100 mg dispersible tablet Plus Standard of Care described in the Control Group Doses of tuberculosis treatment: Isoniazid 10 mg/kg (range 7-15 mg/kg)/day; maximum dose 300 mg/day for 6 months. Rifampicin 15 mg/kg (range 10-20 mg/kg)/day; maximum dose 600 mg/day for 6 months. Pyrazinamide 35 mg/kg (range 30-40 mg/kg)/day for 2 months. Ethambutol 20 mg/kg (range 15-25 mg/kg)/day for 2 months.

Treatment for CMV and for tuberculosis. Fixed-dose dispersible tablet of rifampicin, isoniazid, pyrazinamide (75/50/150 mg) Fixed-dose dispersible tablet of rifampicin/isoniazid (75/50 mg) Ethambutol 100 mg dispersible tablet Valganciclovir (powder for suspension, 50 mg/mL) oral, 16 mg/kg/12 hours for 15 days, Plus Standard of Care described in the Control Group Doses of tuberculosis treatment: Isoniazid 10 mg/kg (range 7-15 mg/kg)/day; maximum dose 300 mg/day for 6 months. Rifampicin 15 mg/kg (range 10-20 mg/kg)/day; maximum dose 600 mg/day for 6 months. Pyrazinamide 35 mg/kg (range 30-40 mg/kg)/day for 2 months. Ethambutol 20 mg/kg (range 15-25 mg/kg)/day for 2 months.

Outcomes

Primary Outcome Measures

Mortality
The primary endpoint of the study is all-cause mortality, focusing on the short term (up to 15-days) and long-term (up to 1-year) mortality. Mortality will be calculated using all-cause mortality after the admission over all the trial time.

Secondary Outcome Measures

Days with oxygen therapy
1. Duration of oxygen requirements (in days, from the first requirement until definitive withdrawal, being day 1 the first day of oxygen requirement).
Days of hospitalization
2. Cumulative days of hospitalization from discharge to day +365 after enrollment
Serious Adverse Events
Serious Adverse Events (SAEs), this is, grade 3 and 4 AEs.
Adverse Reactions
Adverse Reactions (AR)
Notable Adverse Events
Adverse events (AEs) requiring stop of investigational medical product (IMP), all AEs relevant for risk/benefit ratio, including infections, liver toxicity, neurological and optic toxicity, renal, hematological and any AE grade 1, 2, 3 or 4 that the investigator estimates to be relevant
Immune-reconstitution inflammatory syndrome
Incidence of TB-related immune-reconstitution inflammatory syndrome (IRIS)
Baseline cytomegalovirus prevalence
Baseline prevalence of CMV infection and CMV-attributable pneumonia (based in a CMV viral load threshold) in recruited HIV-infected infants with severe pneumonia
Baseline tuberculosis prevalence
Baseline prevalence of microbiological confirmed and unconfirmed TB (according to Graham criteria, Updated Clinical Case Definitions for Classification of Intrathoracic Tuberculosis in Children 2015) in recruited HIV-infected patients with severe pneumonia
Tuberculosis incidence
New confirmed and unconfirmed TB cases according to Graham criteria during 1-year of follow-up among patients without TB-T
Deaths attributable to tuberculosis
Proportion of confirmed and unconfirmed TB, according to Graham criteria, in died children
CMV prevalence in died participants
Proportion of CMV infection in died children
CMV Molecular response to treatment
Reduction of quantitative CMV viral load in blood and saliva in infants treated with valganciclovir from enrollment to day +15
TB-lipoarabinomannan (LAM) sensitivity and specificity
To assess the diagnostic accuracy (sensitivity and specificity) of TB-LAM for the diagnosis of confirmed TB (reference: positive Xpert Mycobacterium tuberculosis (MTB)/RIF Ultra in feces and/or NPA)
Quality-adjusted life expectancy
Economic evaluation for quality-adjusted life expectancy
Per-patient cost
Economic evaluation of the treatments (per-patient cost)

Full Information

First Posted
April 10, 2019
Last Updated
February 28, 2023
Sponsor
Hospital Universitario 12 de Octubre
Collaborators
University Hospital, Bordeaux, Institut National de la Santé Et de la Recherche Médicale, France, PENTA Foundation, Centre Hospitalier Cocody, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Eduardo Mondlane University, Centro de Investigação em Saúde de Manhiça, Stichting Katholieke Universiteit, Barcelona Institute for Global Health, University of Lincoln, Makerere University, University Teaching Hospital, Lusaka, Zambia, University of Zimbabwe, Kamuzu Central Hospital, Servicio Madrileño de Salud (SERMAS)
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1. Study Identification

Unique Protocol Identification Number
NCT03915366
Brief Title
Empirical Treatment Against Cytomegalovirus and Tuberculosis in HIV-infected Infants With Severe Pneumonia
Acronym
EMPIRICAL
Official Title
Empirical Treatment Against Cytomegalovirus and Tuberculosis in HIV-infected Infants With Severe Pneumonia: a Multicenter, Open-label Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitario 12 de Octubre
Collaborators
University Hospital, Bordeaux, Institut National de la Santé Et de la Recherche Médicale, France, PENTA Foundation, Centre Hospitalier Cocody, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Eduardo Mondlane University, Centro de Investigação em Saúde de Manhiça, Stichting Katholieke Universiteit, Barcelona Institute for Global Health, University of Lincoln, Makerere University, University Teaching Hospital, Lusaka, Zambia, University of Zimbabwe, Kamuzu Central Hospital, Servicio Madrileño de Salud (SERMAS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This trial will evaluate whether empirical treatment against cytomegalovirus and tuberculosis improves survival of HIV-infected infants with severe pneumonia.
Detailed Description
Pneumonia is the main cause of death in Human Immunodeficiency Virus (HIV)-infected children. A significant number of undiagnosed or poorly treated HIV-infected children present to health services with severe pneumonia. World Health Organization (WHO) guidelines to treat severe pneumonia in HIV-infected infants include empirical treatment against common bacteria plus Pneumocystis jirovecii. Although this approach has contributed to reducing overall case fatality rates, mortality in this particularly vulnerable group remains unacceptably high. Autopsy studies in Africa have shown that cytomegalovirus (CMV) infection and tuberculosis (TB) are important underdiagnosed and undertreated causes of deaths. Our objective is to evaluate whether empirical treatment against cytomegalovirus and tuberculosis improves survival of HIV-infected infants with severe pneumonia. A randomized factorial clinical trial will be conducted in six sub-Saharan African countries to evaluate the safety and efficacy of empirical treatment against cytomegalovirus and tuberculosis in HIV-infected infants aged 28 days to 365 days admitted to hospital with severe pneumonia. The primary outcome is mortality. All HIV-infected infants will receive standard of care (SoC) pneumonia treatment, including antibiotics, cotrimoxazole, and prednisolone. A group of patients will receive SoC, another group will receive valganciclovir plus SoC, another group will receive tuberculosis treatment plus SoC, and another group will receive valganciclovir, tuberculosis treatment, and SoC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, HIV/AIDS, Tuberculosis, Cytomegalovirus Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
624 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care (SoC)
Arm Type
No Intervention
Arm Description
Standard treatment for severe pneumonia and pneumonia in HIV-infected infants: Ceftriaxone 80 mg/k/day or Ampicillin plus Gentamicin ampicillin 50 mg/kg, or benzylpenicillin 50,000 unit/kg im/iv every six hours plus Gentamicin 7.5 mg/kg/im or iv once a day Cotrimoxazole trimethoprim (TMP) 8mg/kg/dose + sulfamethoxazole (SMX) 40mg/kg/dose three times daily Prednisolone 2mg/kg during 7 days, plus 1mg/kg other 7 days, plus 0.5 mg/kg for 7 days
Arm Title
Valganciclovir plus SoC
Arm Type
Experimental
Arm Description
Treatment for cytomegalovirus (CMV) Valganciclovir (powder for suspension, 50 mg/mL) oral, 16 mg/kg/12 hours for 15 days, and Standard or Care as described in Control Group
Arm Title
Tuberculosis Treatment plus SoC
Arm Type
Experimental
Arm Description
Treatment for tuberculosis Fixed-dose dispersible tablet of rifampicin, isoniazid, pyrazinamide (75/50/150 mg) Fixed-dose dispersible tablet of rifampicin/isoniazid (75/50 mg) Ethambutol 100 mg dispersible tablet Plus Standard of Care described in the Control Group Doses of tuberculosis treatment: Isoniazid 10 mg/kg (range 7-15 mg/kg)/day; maximum dose 300 mg/day for 6 months. Rifampicin 15 mg/kg (range 10-20 mg/kg)/day; maximum dose 600 mg/day for 6 months. Pyrazinamide 35 mg/kg (range 30-40 mg/kg)/day for 2 months. Ethambutol 20 mg/kg (range 15-25 mg/kg)/day for 2 months.
Arm Title
Tuberculosis Treatment plus Valganciclovir plus SoC
Arm Type
Experimental
Arm Description
Treatment for CMV and for tuberculosis. Fixed-dose dispersible tablet of rifampicin, isoniazid, pyrazinamide (75/50/150 mg) Fixed-dose dispersible tablet of rifampicin/isoniazid (75/50 mg) Ethambutol 100 mg dispersible tablet Valganciclovir (powder for suspension, 50 mg/mL) oral, 16 mg/kg/12 hours for 15 days, Plus Standard of Care described in the Control Group Doses of tuberculosis treatment: Isoniazid 10 mg/kg (range 7-15 mg/kg)/day; maximum dose 300 mg/day for 6 months. Rifampicin 15 mg/kg (range 10-20 mg/kg)/day; maximum dose 600 mg/day for 6 months. Pyrazinamide 35 mg/kg (range 30-40 mg/kg)/day for 2 months. Ethambutol 20 mg/kg (range 15-25 mg/kg)/day for 2 months.
Intervention Type
Drug
Intervention Name(s)
Valganciclovir Oral Solution [Valcyte]
Other Intervention Name(s)
Treatment for CMV
Intervention Description
Treatment for CMV
Intervention Type
Drug
Intervention Name(s)
Tuberculostatic Agents
Other Intervention Name(s)
Treatment for TB
Intervention Description
Treatment for tuberculosis
Primary Outcome Measure Information:
Title
Mortality
Description
The primary endpoint of the study is all-cause mortality, focusing on the short term (up to 15-days) and long-term (up to 1-year) mortality. Mortality will be calculated using all-cause mortality after the admission over all the trial time.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Days with oxygen therapy
Description
1. Duration of oxygen requirements (in days, from the first requirement until definitive withdrawal, being day 1 the first day of oxygen requirement).
Time Frame
60 days
Title
Days of hospitalization
Description
2. Cumulative days of hospitalization from discharge to day +365 after enrollment
Time Frame
1 year
Title
Serious Adverse Events
Description
Serious Adverse Events (SAEs), this is, grade 3 and 4 AEs.
Time Frame
1 year
Title
Adverse Reactions
Description
Adverse Reactions (AR)
Time Frame
1 year
Title
Notable Adverse Events
Description
Adverse events (AEs) requiring stop of investigational medical product (IMP), all AEs relevant for risk/benefit ratio, including infections, liver toxicity, neurological and optic toxicity, renal, hematological and any AE grade 1, 2, 3 or 4 that the investigator estimates to be relevant
Time Frame
1 year
Title
Immune-reconstitution inflammatory syndrome
Description
Incidence of TB-related immune-reconstitution inflammatory syndrome (IRIS)
Time Frame
6 months
Title
Baseline cytomegalovirus prevalence
Description
Baseline prevalence of CMV infection and CMV-attributable pneumonia (based in a CMV viral load threshold) in recruited HIV-infected infants with severe pneumonia
Time Frame
30 days
Title
Baseline tuberculosis prevalence
Description
Baseline prevalence of microbiological confirmed and unconfirmed TB (according to Graham criteria, Updated Clinical Case Definitions for Classification of Intrathoracic Tuberculosis in Children 2015) in recruited HIV-infected patients with severe pneumonia
Time Frame
60 days
Title
Tuberculosis incidence
Description
New confirmed and unconfirmed TB cases according to Graham criteria during 1-year of follow-up among patients without TB-T
Time Frame
1 year
Title
Deaths attributable to tuberculosis
Description
Proportion of confirmed and unconfirmed TB, according to Graham criteria, in died children
Time Frame
1 year
Title
CMV prevalence in died participants
Description
Proportion of CMV infection in died children
Time Frame
1 year
Title
CMV Molecular response to treatment
Description
Reduction of quantitative CMV viral load in blood and saliva in infants treated with valganciclovir from enrollment to day +15
Time Frame
1 year
Title
TB-lipoarabinomannan (LAM) sensitivity and specificity
Description
To assess the diagnostic accuracy (sensitivity and specificity) of TB-LAM for the diagnosis of confirmed TB (reference: positive Xpert Mycobacterium tuberculosis (MTB)/RIF Ultra in feces and/or NPA)
Time Frame
1 year
Title
Quality-adjusted life expectancy
Description
Economic evaluation for quality-adjusted life expectancy
Time Frame
1 year
Title
Per-patient cost
Description
Economic evaluation of the treatments (per-patient cost)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Days
Maximum Age & Unit of Time
365 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 28 days to 365 days of age Pneumonia defined as chest indrawing or fast breathing for age, for infants 28 to 60 days of age ≥60 breaths per minute and for infants 61 to 365 days of age, ≥50 breaths per minute. Current hospitalization due to pneumonia with criteria for parenteral antibiotics (1 or more criteria) Chest indrawing with HIV infection No improvement with oral treatment. One or more danger signs according to WHO 5,44,45 Central cyanosis or saturation of O2 <90% Severe respiratory distress, e.g. grunting or very severe chest indrawing Signs of pneumonia with a general danger sign: Unable to drink or breastfeed Persisting vomiting Convulsions in the last 24 hours Lethargic or unconscious Stridor while calm Severe malnutrition HIV-confirmed infection (with at least one molecular method: DNA polymerase chain reaction (PCR) or RNA PCR/viral load). Informed consent obtained Exclusion Criteria: Clinical TB (pulmonary or extrapulmonary) diagnosis, defined as the necessity of TB-T prescribed by a physician, at the moment of randomization Known bacteriologically confirmed TB case (at least one biological specimen positive by culture or Xpert MTB/RIF) at the moment of randomization Patient previously treated for TB or currently on treatment for TB Documented evidence of close TB exposure (household contact of a patient with documented TB during the lifetime of the child, or currently receiving TB-T) Pure wheezers defined as a clear clinical improvement after a bronchodilator test (give a challenge of rapid-acting inhaled bronchodilator for up to three times 15-20 minutes apart. Count the breaths and look for chest indrawing again, and then re-classify) Active malignancies Systemic immunosuppressive medications. Steroids will be considered to be immunosuppressing only if >2 mg/kg of prednisone or equivalent during >15 days Evidence of condition other than HIV and pneumonia which precludes, to the judgment of the clinical researcher, enrollment in this trial due to risk for the patient. In case of doubt, the Trial Management Team will be contacted to assess eligibility Less than 2.5 kg of weight Hb <6 g/dL in the screening blood test or in a test done in the last 48 hours. Transfusion is permitted to achieve >6 g/dL if the patient's state allows it. In case a transfusion is administered, the patient can be enrolled Neutropenia <500 /mm3 in the screening blood test or in a test done in the last 48 hours. Repeating the test is allowed to check eligibility
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alfredo Tagarro, MD, PhD
Phone
+34917792621
Email
alfredo.tagarro@salud.madrid.org
First Name & Middle Initial & Last Name or Official Title & Degree
Pablo Rojo, MD, PhD
Phone
+34917792621
Email
pablorojoconejo@aim.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cinta Moraleda, MD, PhD
Organizational Affiliation
Fundación para la Investigación Biomédica del Hospital 12 de Octubre
Official's Role
Study Chair
Facility Information:
Facility Name
Programme PACCI. Centre Hospitalier Cocody.
City
Abidjan
Country
Côte D'Ivoire
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raoul Moh
Facility Name
Université de Bourdeaux
City
Bourdeaux
Country
France
Individual Site Status
Active, not recruiting
Facility Name
INSERM
City
Toulouse
Country
France
Individual Site Status
Active, not recruiting
Facility Name
PENTA Foundation
City
Padova
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Malawi Liverpool Welcome Trust. Queen Elizabeth Central Hospital College of Medicine
City
Blantyre
Country
Malawi
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pui Ying Iroh Tam
Facility Name
Cemtro de Investigaçao em Saúde da Manhiça
City
Manhiça
Country
Mozambique
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nelson Tembe
Facility Name
Hospital Central Maputo
City
Maputo
Country
Mozambique
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Buck
Facility Name
Stichting Katholieke Universiteit Radboudumc
City
Nimega
Country
Netherlands
Individual Site Status
Active, not recruiting
Facility Name
Fundación para la Investigación Biomédica del Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Makerere University - Mulago Hospital
City
Kampala
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Musiime
Facility Name
University of Lincoln
City
Lincoln
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Lusaka Teaching Hospital
City
Lusaka
Country
Zambia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chisala Chabala
Facility Name
University of Zimbabwe Clinical Research Centre
City
Harare
Country
Zimbabwe
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hilda A Mujuru

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After principal results, addressing primary and secondary objectives will be published. A final repository will be chosen for anonymized data sharing, and transparency after the trial is closed, according to the funder (EDCTP) rules and recommendations, unless national laws impede it.
IPD Sharing Time Frame
Within 12 months of the completion of the study.
IPD Sharing Access Criteria
The repository will be public-available by concrete permission of the Clinical Trial Unit. Those interested in having the database or any of its subsets should provide concrete research proposal that may be accepted under citation condition.
Citations:
PubMed Identifier
35761406
Citation
Rojo P, Moraleda C, Tagarro A, Dominguez-Rodriguez S, Castillo LM, Tato LMP, Lopez AS, Manukyan L, Marcy O, Leroy V, Nardone A, Burger D, Bassat Q, Bates M, Moh R, Iroh Tam PY, Mvalo T, Magallhaes J, Buck WC, Sacarlal J, Musiime V, Chabala C, Mujuru HA. Empirical treatment against cytomegalovirus and tuberculosis in HIV-infected infants with severe pneumonia: study protocol for a multicenter, open-label randomized controlled clinical trial. Trials. 2022 Jun 27;23(1):531. doi: 10.1186/s13063-022-06203-1.
Results Reference
derived

Learn more about this trial

Empirical Treatment Against Cytomegalovirus and Tuberculosis in HIV-infected Infants With Severe Pneumonia

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