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CTRI Number  CTRI/2021/07/034907 [Registered on: 15/07/2021] Trial Registered Prospectively
Last Modified On: 15/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of combination antifungal therapy (Liposomal Amphotericin B and Posaconazole) in Mucormycosis 
Scientific Title of Study   A prospective, open-label, randomisation-controlled trial of combination antifungal therapy (Liposomal Amphotericin B and Posaconazole) vs single antifungal (Liposomal Amphotericin B) for initial treatment in Mucormycosis (ComPLiMenT Trial) 
Trial Acronym  ComPLiMenT Trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ved Prakash Meena 
Designation  Assistant professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Medicine office, Department of Medicine, 3rd floor, Teaching block, AIIMS, New Delhi (110029)

South
DELHI
110029
India 
Phone  9911870646  
Fax    
Email  vpmahar05@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ved Prakash Meena 
Designation  Assistant professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Medicine office, Department of Medicine, 3rd floor, Teaching block, AIIMS, New Delhi (110029)


DELHI
110029
India 
Phone  9911870646  
Fax    
Email  vpmahar05@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rohit Kumar 
Designation  Senior resident ( infectious diseases)  
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Medicine office, Department of Medicine, 3rd floor, Teaching block, AIIMS, New Delhi (110029)

South
DELHI
110029
India 
Phone  9999597994  
Fax    
Email  drrohitkgarg@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, New Delhi 
 
Primary Sponsor  
Name  AIIMS Department of Medicine  
Address  Medicine office, Department of Medicine, AIIMS, New Delhi 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ved Prakash Meena  AIIMS, New Delhi  Medicine Office, Department of Medicine, 3rd floor, Teaching block
South
DELHI 
9911870646

vpmahar05@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Institutional Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B46||Zygomycosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Combination of Liposomal Amphotericin B plus Tablet Posaconazole  In intervention arm, study particiants will receive combination of Liposomal Amphotericin B plus Tablet Posaconazole Dose - 3mg/Kg iv OD for 3 weeks in initial therapy Tab Posaconazole 300 mg BD on Day 1 followed by 300 mg OD x 3 weeks 
Comparator Agent  Monotherapy Liposomal Amphotericin B  In control arm, study particiants will recieve only Liposomal Amphotericin B in initial therapy Dose - 3mg/Kg iv OD for 3 weeks in initial therapy 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  All patients aged 18 years or more, newly diagnosed probable (clinical and radiological) or proven invasive mucormycosis will be included. 
 
ExclusionCriteria 
Details  1 Patients not willing to consent.
2 Patients with more than 5 days of primary antifungal therapy
3 Patients unable to receive enteral medications.
4 Co-existing conditions precluding the use of both Amphotericin B or Posaconazole
a Liposomal Amphotericin B – history of hypersensitivity
b Posaconazole – H/o hypersensitivity (other azoles), Concurrent drugs (Sirolimus: can result in sirolimus toxicity; CYP3A4 substrates (pimozide, quinidine): can result in QTc interval prolongation and cases of Torsades de Pointes; HMG-CoA Reductase Inhibitors Primarily Metabolized Through CYP3A4: can lead to rhabdomyolysis, Ergot alkaloids: can result in ergotism drug interactions); Transaminitis ( AST or ALT >5 times ULN)
5 Patients who are critically ill/ hemodynamic instability
6 Patients with active moderate and severe COVID19 illness at the time of recruitment
7 Breastfeeding/ pregnancy
8 Patient enrolled in other ongoing prospective drug trials for IM
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Complete or partial response at week 3  3 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1.Complete response at week 6 and week 12
 
6 weeks, 12 weeks 

2.Increased survival at week 12, 6 months and 12 months.

 
3, 6 and 12 months 
3.Reduction in all-cause mortality  12 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   19/07/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Mucormycosis is caused by fungi of the order Mucorales. It is characterized by an angio-invasive disease leading to necrotizing arteritis of involved tissues. It most commonly affects immunocompromised patients. Untreated mucormycosis is almost always fatal.

Even after more than one year following the origin of the pandemic, the pathogenesis of COVID19 remains partially understood and understanding of the same continues to evolve with time. As the highly infectious virus continues to give rise to new cases globally, one of the emerging concerns is serious upsurge in the number of cases of mucormycosis. It remains to be seen if this increasing incidence of mucormycosis in COVID19 is related to the illness itself, the steroids and immunomodulators administered for treatment, or the worsening of underlying predisposing factors in the socio-economic upheaval caused by the pandemic.

The management of mucormycosis includes a combination of surgical resection of affected tissues combined with antifungal therapy. Polyenes (Amphotericin B) form the backbone of antifungal therapy in mucormycosis and have been the standard of care for so many years. In addition, newer agents such as Posaconazole (or isavuconazole) have been approved as salvage therapy. Unfortunately, despite adequate surgery and initial management with Amphotericin B, mortality rates in cases of mucormycosis are remarkably high. Considering the poor outcome, there is increasing interest in focusing on the role of combination antifungal therapy in the treatment of mucormycosis. The ongoing COVID19 pandemic provides us a grim scenario in terms of the number of cases of mucormycosis. However, the current situation also provides us with an opportunity to conduct a prospective clinical trial to evaluate the role of combination therapy of polyenes and azoles.

We intend to conduct following prospective, open-label, randomized control trial to evaluate the benefit of combination antifungal therapy in the treatment of mucormycosis. 
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