Visceral LeishmaniasisPhase 3NCT00255567
Efficacy/Safety of Sodium Stibogluconate (SSG) Versus Paromomycin (PM) and SSG/PM Combination to Treat V Leishmaniasis
A Phase 3 study testing Sodium Stibogluconate, Paromomycin sulphate and SSG and Paromomycin sulphate in people with Visceral Leishmaniasis, run by Drugs for Neglected Diseases at 5 sites in 4 countries.
Trial summary
The purpose of this study is to assess the efficacy and safety of SSG 30 days alone, PM 21 days alone and SSG and PM as a combination course of 17 days in the treatment of patients with VL. Read more about this study
- Who is it for?
- Ages 4 to 60 years
- Conditions the study is for
- Visceral Leishmaniasis
- What is being tested?
- Sodium Stibogluconate, Paromomycin sulphate and SSG and Paromomycin sulphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,142 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Nov 2004to Jan 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients for whom written informed consent has been signed by the patients themselves (if aged 18 years and over) or by parents(s) or legal guardian for patients under 18 years of age.
- Patients aged between 4 and 60 years (inclusive) who are able to comply with the protocol. It is justified to include children because they represent more than 50% of VL cases.
- Patients with clinical signs and symptoms of VL and diagnosis confirmed by visualization of parasites in tissue samples (spleen, lymph node or bone marrow) on microscopy.
Who cannot join
- Patients who have received any anti-leishmanial drug in the last 6 months.
- Patients with a negative splenic / lymph node / bone marrow smears.
- Patients with a clinical contraindication to splenic/lymph node/ bone marrow aspirates.
- Patients with severe protein and or caloric malnutrition (Kwashiokor or marasmus)
- Patients with previous hypersensitivity reaction to SSG or aminoglycosides.
- Patients suffering from a concomitant severe infection such as TB or any other serious underlying disease (cardiac, renal, hepatic) which would preclude evaluation of the patients response to study medication.
Show all 15Show fewer
- Patients suffering from other conditions associated with splenomegaly such as schistosomiasis.
- Patients with previous history of cardiac arrhythmia or an abnormal ECG
- Patients who are pregnant or lactating.
- Patients with haemoglobin < 5gm/dl.
- Patients with WBC < 1 x 10³/mm³.
- Patients with platelets < 40,000/mm³.
- Patients with liver function tests more than three times the normal range
- Patients with serum creatinine outside the normal range for age and gender
- Patients with pre-existing clinical hearing loss.
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
About this study
Official title: A Multicentre Comparative Trial of Efficacy and Safety of Sodium Stibogluconate (SSG) Versus Paromomycin (PM) Versus Combination of SSG and PM as the First Line Treatment for Visceral Leishmaniasis in Ethiopia, Kenya and Sudan
The purpose of this study is to assess the efficacy and safety of SSG 30 days alone, PM 21 days alone and SSG and PM as a combination course of 17 days in the treatment of patients with VL.
Read the detailed description
Currently in the three countries, Sudan, Kenya and Ethiopia many of the patients present themselves in remote areas and need to be treated in relative resource poor settings. It is for this reason that standardised treatment with proven efficacy is much needed. A shorter course of treatment is not only advantageous for the patient but also reduces the overall case load in the clinics thus reducing the risk of disease outbreaks in already immuno-compromised kala-azar patients. Paromomycin, either alone or in combination with SSG would decrease the treatment duration substantially. An additional added value of combination therapy is that it is likely to reduce the chances of development of parasite resistance against the individual drugs.
Leishmaniasis experts in the three countries are in agreement that there are potential benefits of the combination treatment of SSG and PM and that its efficacy should be evaluated with the view to introduce this protocol if proven efficacious and safe. There is ample circumstantial evidence of the use of this combination therapy and its efficacy and tolerability as a standardized protocol. This can only be confirmed through a randomised controlled study with 6 months follow up.
- Conditions
- Visceral Leishmaniasis
- Being tested
- Sodium Stibogluconate, Paromomycin sulphate, SSG and Paromomycin sulphate
- Keywords
- Visceral Leishmaniasis, Combination
- Medical subject headings
- Leishmaniasis, Visceral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium StibogluconateDrug
Sodium Stibogluconate 20mg/kg/day for 30 days
Paromomycin sulphateDrug
Paromomycin sulphate
SSG and Paromomycin sulphateDrug
SSG and Paromomycin Sulphate 17 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Sodium Stibogluconate (30 days) Receives: Drug: Sodium Stibogluconate |
| 2 | Experimental | Paromomycin Sulphate (21 days) Receives: Drug: Paromomycin sulphate |
| 3 | Experimental | Sodium Stibogluconate + Paromomycin Sulphate (17 days) Receives: Drug: SSG and Paromomycin sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
parasitological clearance at 6 months post treatment by splenic, lymph node, or bone marrow smear.
Measured: 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startNov 2004
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Visceral LeishmaniasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drugs for Neglected Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manica Balasegaram, Study director, Drugs for Neglected Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00255567
- Sponsor's protocol ID
- DNDi-LEAP0104
- Status last verified
- Mar 2016
- First submitted
- 16 Nov 2005
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Musa A, Khalil E, Hailu A, Olobo J, Balasegaram M, Omollo R, Edwards T, Rashid J, Mbui J, Musa B, Abuzaid AA, Ahmed O, Fadlalla A, El-Hassan A, Mueller M, Mucee G, Njoroge S, Manduku V, Mutuma G, Apadet L, Lodenyo H, Mutea D, Kirigi G, Yifru S, Mengistu G, Hurissa Z, Hailu W, Weldegebreal T, Tafes H, Mekonnen Y, Makonnen E, Ndegwa S, Sagaki P, Kimutai R, Kesusu J, Owiti R, Ellis S, Wasunna M. Sodium stibogluconate (SSG) & paromomycin combination compared to SSG for visceral leishmaniasis in East Africa: a randomised controlled trial. PLoS Negl Trop Dis. 2012;6(6):e1674. doi: 10.1371/journal.pntd.0001674. Epub 2012 Jun 19.
PubMed 22724029Musa AM, Younis B, Fadlalla A, Royce C, Balasegaram M, Wasunna M, Hailu A, Edwards T, Omollo R, Mudawi M, Kokwaro G, El-Hassan A, Khalil E. Paromomycin for the treatment of visceral leishmaniasis in Sudan: a randomized, open-label, dose-finding study. PLoS Negl Trop Dis. 2010 Oct 26;4(10):e855. doi: 10.1371/journal.pntd.0000855.
PubMed 21049063
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Comparative Trial of Efficacy and Safety of Sodium Stibogluconate (SSG) Versus Paromomycin (PM) Versus Combination of SSG and PM as the First Line Treatment for Visceral Leishmaniasis in Ethiopia, Kenya and Sudan
- ClinicalTrials.gov ID
- NCT00255567
- Acronym / sponsor ID
- DNDi-LEAP0104
- Conditions
- Visceral Leishmaniasis
- Keywords
- Visceral Leishmaniasis, Combination
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,142 participants (actual)
- Lead sponsor
- Drugs for Neglected DiseasesUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 21 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy and safety of SSG 30 days alone, PM 21 days alone and SSG and PM as a combination course of 17 days in the treatment of patients with VL.
Detailed description
Currently in the three countries, Sudan, Kenya and Ethiopia many of the patients present themselves in remote areas and need to be treated in relative resource poor settings. It is for this reason that standardised treatment with proven efficacy is much needed. A shorter course of treatment is not only advantageous for the patient but also reduces the overall case load in the clinics thus reducing the risk of disease outbreaks in already immuno-compromised kala-azar patients. Paromomycin, either alone or in combination with SSG would decrease the treatment duration substantially. An additional added value of combination therapy is that it is likely to reduce the chances of development of parasite resistance against the individual drugs.
Leishmaniasis experts in the three countries are in agreement that there are potential benefits of the combination treatment of SSG and PM and that its efficacy should be evaluated with the view to introduce this protocol if proven efficacious and safe. There is ample circumstantial evidence of the use of this combination therapy and its efficacy and tolerability as a standardized protocol. This can only be confirmed through a randomised controlled study with 6 months follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Sodium StibogluconateSodium Stibogluconate (30 days) |
| 2 | Experimental | Drug: Paromomycin sulphateParomomycin Sulphate (21 days) |
| 3 | Experimental | Drug: SSG and Paromomycin sulphateSodium Stibogluconate + Paromomycin Sulphate (17 days) |
Who may qualify
- Ages
- 4 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients for whom written informed consent has been signed by the patients themselves (if aged 18 years and over) or by parents(s) or legal guardian for patients under 18 years of age.
- Patients aged between 4 and 60 years (inclusive) who are able to comply with the protocol. It is justified to include children because they represent more than 50% of VL cases.
- Patients with clinical signs and symptoms of VL and diagnosis confirmed by visualization of parasites in tissue samples (spleen, lymph node or bone marrow) on microscopy.
Key exclusion criteria (15 listed)
- Patients who have received any anti-leishmanial drug in the last 6 months.
- Patients with a negative splenic / lymph node / bone marrow smears.
- Patients with a clinical contraindication to splenic/lymph node/ bone marrow aspirates.
- Patients with severe protein and or caloric malnutrition (Kwashiokor or marasmus)
- Patients with previous hypersensitivity reaction to SSG or aminoglycosides.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium StibogluconateSodium Stibogluconate 20mg/kg/day for 30 days | Drug | 1 |
| Paromomycin sulphateParomomycin sulphate | Drug | 2 |
| SSG and Paromomycin sulphateSSG and Paromomycin Sulphate 17 days | Drug | 3 |
Primary outcome
parasitological clearance at 6 months post treatment by splenic, lymph node, or bone marrow smear.
Time frame: 6 months post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
- Derived from this study: PubMed 22724029Musa A, Khalil E, Hailu A, Olobo J, Balasegaram M, Omollo R, Edwards T, Rashid J, Mbui J, Musa B, Abuzaid AA, Ahmed O, Fadlalla A, El-Hassan A, Mueller M, Mucee G, Njoroge S, Manduku V, Mutuma G, Apadet L, Lodenyo H, Mutea D, Kirigi G, Yifru S, Mengistu G, Hurissa Z, Hailu W, Weldegebreal T, Tafes H, Mekonnen Y, Makonnen E, Ndegwa S, Sagaki P, Kimutai R, Kesusu J, Owiti R, Ellis S, Wasunna M. Sodium stibogluconate (SSG) & paromomycin combination compared to SSG for visceral leishmaniasis in East Africa: a randomised controlled trial. PLoS Negl Trop Dis. 2012;6(6):e1674. doi: 10.1371/journal.pntd.0001674. Epub 2012 Jun 19.
- Derived from this study: PubMed 21049063Musa AM, Younis B, Fadlalla A, Royce C, Balasegaram M, Wasunna M, Hailu A, Edwards T, Omollo R, Mudawi M, Kokwaro G, El-Hassan A, Khalil E. Paromomycin for the treatment of visceral leishmaniasis in Sudan: a randomized, open-label, dose-finding study. PLoS Negl Trop Dis. 2010 Oct 26;4(10):e855. doi: 10.1371/journal.pntd.0000855.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manica Balasegaram study director
Drugs for Neglected Diseases
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sodium Stibogluconate, Paromomycin sulphate and SSG and Paromomycin sulphate in people with Visceral Leishmaniasis, run by Drugs for Neglected Diseases at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Ethiopia, Kenya, Sudan, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
parasitological clearance at 6 months post treatment by splenic, lymph node, or bone marrow smear. (time frame: 6 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00255567, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2016.