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1 Clinical Trial Details (PDF Generation Date :- Sat, 06 Oct :04:10 GMT) CTRI Number Last Modified On 02/06/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/08/ [Registered on: 16/08/2012] - Trial Registered Prospectively No Interventional Drug Non-randomized, Multiple Arm Trial An open-label, prospective, non randomised, non comparative, multicenter, observational pharmacovigilence study of the safety and effectiveness of new treatment modalities to treat VL in public sector of. A Pilot Project To Evaluate The Safety And Effectiveness Of New Treatment Modalities For The Management Of Visceral Leishmaniasis (VL) In The Endemic Regions Of Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) VL PV 2011 Designation Affiliation Protocol Number Details of Principal Investigator Dr Pradeep Das Director Phone Fax Designation Affiliation Rajendra Memorial Research Institute of Medical Sciences Rajendra Memorial Research Institute of Medical Sciences, (n Council of Medical Research) Agam Kuan, Patna Patna drpradeep.das@gmail.com Details Contact Person (Scientific Query) Dr Bhawna Sharma Head, Regional Office Phone Fax Designation Affiliation Drugs for Neglected Diseases initiative Drugs for Neglected Diseases initiative ICMR, 2nd Campus, Room no.3, 1st Floor TB Association Building, 3 Red Cross Road, New Delhi New Delhi DELHI bsharma@dndi.org Details Contact Person (Public Query) Dr Bhawna Sharma Head, Regional Office Drugs for Neglected Diseases initiative Drugs for Neglected Diseases initiative ICMR, 2nd Campus, Room no.3, 1st Floor TB Association Building, 3 Red Cross Road, New Delhi New Delhi DELHI page 1 / 7

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax > Drugs for Neglected Diseases initiative (DNDi) Source of Monetary or Material Support Primary Sponsor Details Drugs for Neglected Diseases initiative DNDi 15, Chemin Louis-Dunant, 1202, Geneva-Switzerland Tel: +41(0) /34 Fax: +41 (0) Type of Sponsor NIL List of Countries of Principal Investigator Dr Vinay Kumar Yadav Dr Satyendra Kumar Gupta Other [Not for Profit Organozation] NIL of Site Site Phone/Fax/ Civil Surgeon Office, Civil Surgeon Office, Sadar Hospital Chhapra Sadar Hospital Chhapra Goraul PHC Goraul Primary Health Center Dr Gaurav Mitra Hajipur Hospital Hajipur Sadar Hospital Dr Vibesh Prasad Singh Civil Surgeon Hajipur Hospital Hajipur Hospital, District- Bihar Dr Anil Kumar Manhar MOIC, Manhar Primary Health Center Dr Akhileshwar Kumar Dr Birendra Kumar Dr Narendra Kumar Dr Sunil Keshri (PHC) Dariyapur (PHC) Mahua (PHC) Parsa (PHC) Raghopur l.com co.in ail.com MOIC,Primary Health Centre (PHC) Dariyapur m (PHC) Mahua MOIC,Primary Health Centre (PHC) Parsa (PHC) Raghopur ail.com page 2 / 7

3 Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Dr Anil Kumar Sinha Dr Pradeep Das Dr Harish Chandra Prasad Dr R N Tiwary Dr Ravi Shankar Singh Dr Shambu Nath Singh (PHC) Rajendra Memorial Research Institute of Medical Sciences Referral Hospital, Baniyapur Referral Hospital, Marhourah (PHC) Rajendra Memorial Research Institute of Medical Sciences, (n Council of Medical Research) Agam Kuan, Patna Patna MOIC,Referral Hospital, Baniyapur MOIC,Referral Hospital, Marhourah Sadar Hospital Chhapra Pediatrician,Sadar Hospital Chhapra Sadar Hospital Chhapra Deputy Superintendent (Kala Azar Incharge),Sadar Hospital Chhapra mail.com Vl_vaishali.rks@rediffm ail.com drpradeep.das@gmail.c om phcbaniyapur@gmail.c om phcmarhoarh@gmail.co m sadarhospital.cpr@gma il.com sadarhospital.cpr@gma il.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? London School of Hygiene & Tropical Medicine Ethics Committee Approved 21/10/2011 Yes RMRI Ethics Committee Approved 20/07/2011 No RMRI Ethics Committee Approved 19/07/2012 No Status Date Notified 14/07/2011 Health Type Patients Condition Visceral Leishmaniasis (VL), also known as Kala Azar Type Details Intervention Treatment-1: Miltefosine Capsule and Paromomycin injection Treatment 1: Miltefosine Capsules (50 mg and 10 mg) & Paromomycin Injections combination treatment given as follows: Miltefosine given orally for 10 days (day 1-10) at 100mg daily for adults over 25kg, 50mg daily for adults under 25kg, and 2.5mg/kg daily for children plus paromomycin 11mg/kg base given page 3 / 7

4 Inclusion Criteria Intervention Intervention Age From Age To Gender Details Treatment-2:Ambisome infusion and Miltefosine Capsule intramuscularly for 10 days (day 1-10): this treatment will be used in at least 5 PHCs. Treatment 2: AmBisome 5mg/kg infusion on day 1 plus Miltefosine capsules given orally at 100mg daily for adults over 25kg, 50mg daily for adults under 25kg, and 2.5mg/kg daily for children for 7 days (days 2-8): this treatment will be used in at least 5PHCs. Treatment-3:Ambisome infusion Treatment 3: Single dose AmBisome 10mg/kg infusion on day 1: this treatment will be used at hospital and referral level in the district(s) involved Year(s) Year(s) Both Inclusion Criteria Primary cases: all new cases with clinical features of VL (fever for 2 weeks and splenomegaly) and are rk39 or parasitology positive. Relapse cases: all cases that have previously been treated for VL (but not involving any one of the drugs that are part of the new treatment modality used at that treatment centre), have fever, splenomegaly and are confirmed by parasitology. Written consent to receive one of the new treatment modalities and allow information to be collected as part of a pilot project. Exclusion Criteria Details Exclusion Criteria Pregnant women and women of child bearing age who cannot be assured contraceptive cover will be excluded from all miltefosine containing regimens. These cases may be referred and managed with non-miltefosine new treatment modalities in the nearest district hospital/ designated referral centre. Their exclusion will be recorded within the surveillance register. All patients who have previously been treated with one of the drugs that are part of the new treatment modality in use at that centre will be excluded (e.g. any patient treated with miltefosine monotherapy will not be retreated with a miltefosine combination treatment; any patient treated with high dose AmBisome will not be given single dose AmBisome or an AmBisome combination). Their admission will however be recorded within the surveillance register. All known HIV+ patients (see special cases below) patients will be treated with alternative regimens. Their admission will however be recorded within the surveillance register. All PKDL patients will be treated with alternative regimens. Their admission will however be recorded within the surveillance register. All patients with a history of allergy or hypersensitivity to the relevant drug Special cases A category of special cases will be defined on entry based on the classifications below. These cases will either be managed by specific treatments (e.g. one particular new treatment modality) and/ or in specialist referral centres. All pregnant women can be included and will be treated with AmBisome 10mg/kg single dose. All pregnant cases treated, or page 4 / 7

5 Method of Generating Random Sequence Method of Concealment Blinding/Masking Not Applicable Not Applicable Open Label patients given a new treatment modality and who become pregnant within one month of end of treatment will be entered into a special pregnancy follow up register. All women of child bearing age who cannot be assured contraceptive cover will be treated with either AmBisome & paromomycin or AmBisome single dose. All patients with signs and symptoms of severe diseases: defined as severe anaemia (i.e. haemoglobin 4 and/ or signs of cardiac failure), renal failure or hepatic failure (e.g. jaundice), serious concomitant infection (e.g. severe pneumonia), severe malnutrition, will be referred to the nearest district hospital or RMRIMS for further specialist management. These patients may be treated with one of the new treatment modalities according to the physician s decision. All patients with proven TB/VL co-infection will be referred to the nearest district hospital or RMRIMS for further specialist management. These patients may be treated with one of the new treatment modalities according to the physician s decision. All children under 2 will be referred to the nearest district hospital or RMRIMS for further specialist management. These patients may be treated with one of the new treatment modalities according to the physician s decision. Note: All patients with proven HIV/ VL co-infection will also be referred to the nearest district hospital or RMRIMS for further specialist management. However, as defined in the exclusion criteria, these patients will not be treated with one of the new treatment modalities. Compassionate high dose therapy with AmBisome or a high dose combination of drugs may be used according to the physician s decision. All consenting patients entering a centre where one of the new treatment modalities is being piloted will be entered in to a register. All patients treated with one of the new treatment modalities will also be entered in the PV programme and compliance survey (step 1 only). Primary Outcome Outcome Timepoints The effectiveness or final proportion cured (success) of the treatments proposed will reach a target of 95%. Therefore the proportion of observed failures will be 5% for each of the proposed treatments. The level of expedited safety events reported (Deaths, Serious and Unexpected Adverse Drug reactions) will be? 2% for each of the proposed treatments. Initial Cure is 10 days and the final cure is 06 months Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 4 Date of First Enrollment () Initial outcome: Initial cured, died, defaulted, treatment stopped, treatment failure, referred to another centre Total Sample Size=7000 Sample Size from = /08/2012 Initial Cure is 10 days page 5 / 7

6 Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary No Date Specified Years=5 Months=0 Days=0 Not Applicable Completed This is an open-label, prospective, non randomised, non comparative, multicenter, observational pharmacovigilence study of the safety and effectiveness of new treatment modalities to treat VL in public sector of. The objectives stated above will be achieved through: 1) The implementation of a PV network to evaluate safety across all the participating VL treatment sites. This will also involve the development of a reporting system for individual Serious and unexpected ADRs to a steering committee and the relevant authorities. 2) The development of a VL treatment and follow up surveillance register (referred to hence as the surveillance register ) listing all patients that receive one of the new treatment modalities in the participating sites and the periodic reporting of aggregated outcome data to the national authorities. Sites: In order to reflect the current situation of health care provision for VL in endemic areas, the project will be implemented in the following structures: - Ministry of health structures from PHC level upwards: most centres and patients to be included in this project will be in this category. - A few key health providers with experience managing VL (e.g. RMRIMS). - In 5 PHCs and 1 district hospital in Vaishalli District, Bihar State, where Médecins Sans Frontières-Spain/OCBA is currently working within the government structures. Treatments to be implemented (new treatment modalities) page 6 / 7

7 Powered by TCPDF ( PDF of Trial i) NON AmBisome Based treatment: targeted for first line administration at the primary health care (PHC) level in a district Treatment 1: MF&PM combination treatment given as follows: Miltefosine given orally for 10 days (day 1-10) at 100mg daily for adults over 25kg, 50mg daily for adults under 25kg, and 2.5mg/kg daily for children plus paromomycin 11mg/kg base given intramuscularly for 10 days (day 1-10): this treatment will be used in at least 5 PHCs. ii) AmBisome Based treatment: targeted for administration where AmBisome is feasible in a district (i.e. PHCs able to maintain cold chain, familiar with amphotericin B administration, or district hospitals). AmBisome based treatment modalities that will be evaluated consist of the following: Treatment 2: AmBisome 5mg/kg on day 1 plus miltefosine given orally at 100mg daily for adults over 25kg, 50mg daily for adults under 25kg, and 2.5mg/kg daily for children for 7 days (days 2-8): this treatment will be used in at least 5PHCs. Treatment 3: Single dose AmBisome 10mg/kg on day 1: this treatment will be used at hospital and referral level in the district(s) involved. page 7 / 7