A Phase 2 interventional study of Trimethoprim-sulfamethoxazole and Placebo in Staphylococcal Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 6 sites in United States. Open to participants aged 6 Months to 85 Years. Per ClinicalTrials.gov, last updated 2016-03-17.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Treatment
The purpose of this clinical trial is to evaluate 2 different antibiotics, drugs that fight bacteria, [clindamycin (CLINDA) and trimethoprim-sulfamethoxazole (TMP-SMX)] and wound care for the outpatient management of uncomplicated skin and soft tissue infections (uSSTIs) in children and adults. The study will occur in areas where community associated methicillin-resistant Staphylococcus (S.) aureus are common. S. aureus is a type of bacteria. A total of 1310 volunteers, greater than or equal to 6 months of age and adults 85 years or younger, non-immunocompromised, with uSSTIs (in particular abscess and/or cellulitis) will be enrolled in this study. Subjects will be treated with one of the following: CLINDA, TMP-SMX, or placebo (contains no medication). Volunteers will be grouped based on the presence of cellulitis or abscess, whether the abscess can be surgically drained, and its size. The subject participation duration for this study is about 6 weeks.
Clinical practice in the treatment of community-onset skin and soft tissue infections (SSTI) has not kept pace with the emergence of methicillin-resistant Staphylococcus aureus (MRSA) in the community. This clinical trial will evaluate clindamycin (CLINDA) and trimethoprim-sulfamethoxazole (TMP-SMX) and wound care for the outpatient management of uncomplicated skin and soft tissue infection (uSSTI) in 3 metropolitan areas, Chicago, Los Angeles, and San Francisco, cities with high prevalence of community acquired (CA)-MRSA. This is a phase IIb multicenter, stratified, randomized, double-blind trial in which enrolled subjects with abscess or cellulitis will be treated with CLINDA, TMP-SMX, or placebo. Participants will include 1310 non-immunocompromised out-patients age 6 months to 85 years with SSTIs not requiring hospital admission. Subjects will undergo a screening/baseline evaluation, including determination of presence and size of abscess and/or presence of cellulitis. Subjects will then be randomized to receive treatment with either CLINDA, TMP-SMX, or placebo depending on whether they have: a larger drainable abscess, defined as greater than 5 cm in diameter in adults and as greater than 3 cm in diameter for ages 6-11 months, greater than 4 cm for ages 1-8 years, and greater than 5 cm for age 9 years and older; a limited drainable abscess, defined as less than or equal to 5 cm for adults and as less than or equal to 3 cm for ages 6-11 months, less than or equal to 4 cm for ages 1-8 years, and less than or equal to 5 cm for age 9 years and older; or cellulitis or erysipelas only. If the diameter of the abscess greater than 5 cm (smaller for children depending on age) or 2 or more sites of skin infection are present the subject will be randomized (1:1) to 10 days of therapy with TMP-SMX or CLINDA. If the diameter of the abscess less than or equal to 5 cm (smaller for children depending on age) then the subject will be randomized (1:1:1) to TMP-SMX, CLINDA or placebo for 10 days. Subjects with cellulitis or erysipelas only will be randomized (1:1) to TMP-SMX or CLINDA for 10 days. Subjects will be provided study drug, instructed in its use, and scheduled for 4 follow-up visits including: wound check (24-48 hours after enrollment); end of therapy (48 hours after completion of therapy); test of cure (7-10 days after completion of therapy); and a final visit at one month after completion of therapy. The primary objectives of this study are: to compare the cure rate of CLINDA to that of TMP-SMX for the treatment of patients with cellulitis or larger abscess at the Test of Cure (TOC) visit and to compare the cure rate of CLINDA, TMP-SMX, and placebo, each in conjunction with surgical drainage for the treatment of subjects with limited abscess at the TOC visit.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 1,310 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.
Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.
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Diagnosis of uncomplicated skin and soft tissue infection (uSSTI), either cellulitis (defined as an inflammation of skin and associated skin structures) or abscess (defined as a circumscribed collection of pus), evidenced by at least 2 of the following localized signs or symptoms on the skin for at least 24 hours:
Exclusion Criteria:
Superficial skin infection only, including:
Systolic blood pressure (SBP) less than an age-specific critical value:
Heart rate greater than an age-specific critical value:
Oral temperature (or equivalent rectal, tympanic membrane, axillary) greater than age-specific critical value:
Infection at an anatomical skin site requiring specialized management or specialized antimicrobial therapy, including:
Complicated skin or soft tissue infection, such as:
History of underlying immunocompromising condition or immunodeficiency, for example:
Limited abscess with or without cellulitis less than or equal to 5 cm in diameter will be randomized to receive a 10-day course a) TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children; or b) CLINDA 300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children; or c) placebo two capsules three times daily.
Drug: Trimethoprim-sulfamethoxazole · Other: Placebo · Drug: Clindamycin
Subjects with cellulitis only or abscess \> 5 cm in diameter, or with 2 or more sites of skin infection will be randomized to receive a 10-day course a) TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children; or b) CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
Drug: Trimethoprim-sulfamethoxazole · Drug: Clindamycin
Trimethoprim-sulfamethoxazole (TMP-SMX) will be administered orally at a dose of 160 mg TMP and 800 mg SMX (as 2 single strength over encapsulated tablets) twice daily (adult or child \> 40 kg dose) or 8-10 mg TMP, 40-50 mg SMX per kg daily, divided into 2 daily doses (child \< 40 kg dose). Study drug will be administered for 10 days.
Placebo capsules will be identical in appearance to the CLINDA and TMP-SMX. Administered 3 times daily for 10 days.
CLINDA (adult dose of 300 mg three times daily; pediatric dose of 25-30 mg/kg/day divided three times daily up to a maximum dose of 900 mg/day). Study drug will be administered for 10 days.
Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Evaluable Population.
Clinical failure is defined as the occurence of any of the following: 1. Lack of resolution at the Test of Cure (TOC) visit in any or all of the following: erythema, tenderness, purulent drainage, swelling, and local warmth. Erythema or tenderness that was considered due the surgical therapy itself (incision and drainage), was not considered to be indicative of clinical failure. 2. Occurrence of a SSTI at another site other than the site(s) under study. 3. Intolerance of study medication or a treatment-limiting adverse reaction necessitating discontinuation of study drug within the first 48 hours. 4. Administration of other antimicrobial therapy for treatment of a SSTI at any time through the TOC visit. 5. Unplanned surgical procedure for the infection under study at any time through the TOC visit. 6. Hospitalization for treatment of active or invasive infection at any time through the TOC visit.
Time frame: Test of cure (TOC) (7-10 days after completion of therapy)
Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Intent-to-Treat (ITT) Population.
Clinical failure is defined as the occurence of any of the following: 1. Lack of resolution at the Test of Cure (TOC) visit in any or all of the following: erythema, tenderness, purulent drainage, swelling, and local warmth. Erythema or tenderness that was considered due the surgical therapy itself (incision and drainage), was not considered to be indicative of clinical failure. 2. Occurrence of a SSTI at another site other than the site(s) under study. 3. Intolerance of study medication or a treatment-limiting adverse reaction necessitating discontinuation of study drug within the first 48 hours. 4. Administration of other antimicrobial therapy for treatment of a SSTI at any time through the TOC visit. 5. Unplanned surgical procedure for the infection under study at any time through the TOC visit. 6. Hospitalization for treatment of active or invasive infection at any time through the TOC visit.
Time frame: Test of cure (TOC) (7-10 days after completion of therapy)
Number of Participants Reporting Adverse Events.
Subjects were issued a Memory Aid to record symptoms for 10 days post product administration. At study visits, the staff reviewed the memory aid and elicited as much information as possible about any reported symptoms. Occurrence of adverse events was solicited in the memory aid and during study visits. Reported symptoms, both solicited and unsolicited, were recorded as Adverse Events.
Time frame: End of Treatment (EOT) (48 hours after completion of therapy); Test of Cure (TOC) (7-10 days after completion of therapy); One Month Follow-up Visit (OMFU)
Number of Participants Reporting Adverse Events That Are Treatment Limiting.
Participants were issued a Memory Aid to record symptoms for 10 days post product administration. At study visits, the staff reviewed the memory aid and elicited as much information as possible about any reported symptoms. Occurrence of adverse events was solicited in the memory aid and during study visits. Reported symptoms, both solicited and unsolicited, were recorded as Adverse Events. For these results, adverse events that resulted in discontinuation of study treatment for the participant were considered treatment limiting.
Time frame: End of Treatment (EOT) (48 hours after completion of therapy); Test of Cure (TOC) (7-10 days after completion of therapy); One Month Follow-up Visit (OMFU)
Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Evaluable Population.
Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure.
Time frame: EOT visit within 48 hours of completion of therapy
Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Intent-to-Treat (ITT) Population.
Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure.
Time frame: EOT visit within 48 hours of completion of therapy
Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Evaluable Population.
Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure, with one addition. At the OMFU, relapse (the return of the original infection after initial improvement) or recurrence (return of skin infection at original site after cure of original infection) of SSTI was scored as clinical failure.
Time frame: OMFU visit
Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Intent-to-Treat (ITT) Population.
Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure, with one addition. At the OMFU, relapse (the return of the original infection after initial improvement) or recurrence (return of skin infection at original site after cure of original infection) of SSTI was scored as clinical failure.
Time frame: OMFU visit
Participants were non-immunocompromised out-patients age 6 months to 85 years with SSTIs not requiring hospital admission were recruited across 6 sites from communities with an anticipated prevalence of community-associated MRSA. Participants were enrolled between April 13, 2009 and January 13, 2015
| Milestone | Cellulitis or Larger Abscess - Clindamycin | Cellulitis or Larger Abscess - TMP-SMX | Limited Abscess - Clindamycin | Limited Abscess - TMP-SMX | Limited Abscess - Placebo |
|---|---|---|---|---|---|
| Started | 264 | 260 | 266 | 263 | 257 |
| Completed | 204 | 194 | 221 | 207 | 175 |
| Not completed | 60 | 66 | 45 | 56 | 82 |
| Withdrew: Adverse event | 23 | 26 | 16 | 20 | 43 |
| Withdrew: Lost to follow-up | 13 | 26 | 22 | 26 | 25 |
| Withdrew: Protocol violation | 6 | 1 | 1 | 2 | 0 |
| Withdrew: Withdrawal by subject | 9 | 5 | 4 | 5 | 9 |
| Withdrew: Physician decision | 3 | 3 | 2 | 3 | 2 |
| Withdrew: Treatment failure | 5 | 5 | 0 | 0 | 1 |
| Withdrew: Randomization error | 1 | 0 | 0 | 0 | 2 |
Clinical failure is defined as the occurence of any of the following: 1. Lack of resolution at the Test of Cure (TOC) visit in any or all of the following: erythema, tenderness, purulent drainage, swelling, and local warmth. Erythema or tenderness that was considered due the surgical therapy itself (incision and drainage), was not considered to be indicative of clinical failure. 2. Occurrence of a SSTI at another site other than the site(s) under study. 3. Intolerance of study medication or a treatment-limiting adverse reaction necessitating discontinuation of study drug within the first 48 hours. 4. Administration of other antimicrobial therapy for treatment of a SSTI at any time through the TOC visit. 5. Unplanned surgical procedure for the infection under study at any time through the TOC visit. 6. Hospitalization for treatment of active or invasive infection at any time through the TOC visit.
| percentage of participants | Cellulitis or Larger Abscess - Clindamycin | Cellulitis or Larger Abscess - TMP-SMX | Limited Abscess - Clindamycin | Limited Abscess - TMP-SMX | Limited Abscess - Placebo |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Evaluable Population. | 89.5 (85.2 to 93.7) | 88.2 (83.7 to 92.7) | 92.9 (89.3 to 96.4) | 92.7 (89.0 to 96.3) | 80.5 (74.8 to 86.1) |
Subjects were issued a Memory Aid to record symptoms for 10 days post product administration. At study visits, the staff reviewed the memory aid and elicited as much information as possible about any reported symptoms. Occurrence of adverse events was solicited in the memory aid and during study visits. Reported symptoms, both solicited and unsolicited, were recorded as Adverse Events.
| participants | Cellulitis or Larger Abscess - Clindamycin | Cellulitis or Larger Abscess - TMP-SMX | Limited Abscess - Clindamycin | Limited Abscess - TMP-SMX | Limited Abscess - Placebo |
|---|---|---|---|---|---|
| Number of Participants Reporting Adverse Events. | 116 | 132 | 119 | 94 | 119 |
Participants were issued a Memory Aid to record symptoms for 10 days post product administration. At study visits, the staff reviewed the memory aid and elicited as much information as possible about any reported symptoms. Occurrence of adverse events was solicited in the memory aid and during study visits. Reported symptoms, both solicited and unsolicited, were recorded as Adverse Events. For these results, adverse events that resulted in discontinuation of study treatment for the participant were considered treatment limiting.
| participants | Cellulitis or Larger Abscess - Clindamycin | Cellulitis or Larger Abscess - TMP-SMX | Limited Abscess - Clindamycin | Limited Abscess - TMP-SMX | Limited Abscess - Placebo |
|---|---|---|---|---|---|
| Number of Participants Reporting Adverse Events That Are Treatment Limiting. | 1 | 0 | 6 | 3 | 4 |
Clinical failure is defined as the occurence of any of the following: 1. Lack of resolution at the Test of Cure (TOC) visit in any or all of the following: erythema, tenderness, purulent drainage, swelling, and local warmth. Erythema or tenderness that was considered due the surgical therapy itself (incision and drainage), was not considered to be indicative of clinical failure. 2. Occurrence of a SSTI at another site other than the site(s) under study. 3. Intolerance of study medication or a treatment-limiting adverse reaction necessitating discontinuation of study drug within the first 48 hours. 4. Administration of other antimicrobial therapy for treatment of a SSTI at any time through the TOC visit. 5. Unplanned surgical procedure for the infection under study at any time through the TOC visit. 6. Hospitalization for treatment of active or invasive infection at any time through the TOC visit.
| percentage of participants | Cellulitis or Larger Abscess - Clindamycin | Cellulitis or Larger Abscess - TMP-SMX | Limited Abscess - Clindamycin | Limited Abscess - TMP-SMX | Limited Abscess - Placebo |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Intent-to-Treat (ITT) Population. | 80.3 (75.2 to 85.4) | 77.7 (72.3 to 83.1) | 83.1 (78.3 to 87.9) | 81.7 (76.8 to 86.7) | 68.9 (62.9 to 74.9) |
Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure.
| percentage of participants | Cellulitis or Larger Abscess - Clindamycin | Cellulitis or Larger Abscess - TMP-SMX | Limited Abscess - Clindamycin | Limited Abscess - TMP-SMX | Limited Abscess - Placebo |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Evaluable Population. | 89.2 (85.0 to 93.3) | 88.3 (83.8 to 92.7) | 90.9 (87.0 to 94.8) | 94.2 (90.9 to 97.5) | 84.9 (80.0 to 89.9) |
Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure.
| percentage of participants | Cellulitis or Larger Abscess - Clindamycin | Cellulitis or Larger Abscess - TMP-SMX | Limited Abscess - Clindamycin | Limited Abscess - TMP-SMX | Limited Abscess - Placebo |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Intent-to-Treat (ITT) Population. | 81.1 (76.1 to 86.0) | 75.4 (70.0 to 80.8) | 78.9 (73.9 to 84.0) | 79.8 (74.8 to 84.9) | 72.4 (66.7 to 78.0) |
Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure, with one addition. At the OMFU, relapse (the return of the original infection after initial improvement) or recurrence (return of skin infection at original site after cure of original infection) of SSTI was scored as clinical failure.
| percentage of participants | Cellulitis or Larger Abscess - Clindamycin | Cellulitis or Larger Abscess - TMP-SMX | Limited Abscess - Clindamycin | Limited Abscess - TMP-SMX | Limited Abscess - Placebo |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Evaluable Population. | 83.9 (78.9 to 88.9) | 78.2 (72.6 to 83.8) | 89.3 (85.1 to 93.5) | 85.0 (80.1 to 89.8) | 73.9 (67.8 to 79.9) |
Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure, with one addition. At the OMFU, relapse (the return of the original infection after initial improvement) or recurrence (return of skin infection at original site after cure of original infection) of SSTI was scored as clinical failure.
| percentage of participants | Cellulitis or Larger Abscess - Clindamycin | Cellulitis or Larger Abscess - TMP-SMX | Limited Abscess - Clindamycin | Limited Abscess - TMP-SMX | Limited Abscess - Placebo |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Intent-to-Treat (ITT) Population. | 73.1 (67.6 to 78.6) | 67.7 (61.8 to 73.6) | 78.6 (73.5 to 83.7) | 73.0 (67.4 to 78.6) | 62.6 (56.5 to 68.8) |
Collected over Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cellulitis or Larger Abscess - Clindamycin | — | 4/264 (1.5%) | 59/264 (22.3%) |
| Cellulitis or Larger Abscess - TMP-SMX | — | 5/260 (1.9%) | 72/260 (27.7%) |
| Limited Abscess - Clindamycin | — | 0/266 (0%) | 61/266 (22.9%) |
| Limited Abscess - TMP-SMX | — | 6/263 (2.3%) | 52/263 (19.8%) |
| Limited Abscess - Placebo | — | 2/257 (0.8%) | 60/257 (23.3%) |
| Event | Cellulitis or Larger Abscess - Clindamycin | Cellulitis or Larger Abscess - TMP-SMX | Limited Abscess - Clindamycin | Limited Abscess - TMP-SMX | Limited Abscess - Placebo |
|---|---|---|---|---|---|
| CellulitisInfections and infestations | 1/264 | 2/260 | 0/266 | 1/263 | 0/257 |
| AbscessInfections and infestations | 1/264 | 0/260 | 0/266 | 2/263 | 0/257 |
| Perirectal AbscessInfections and infestations | 1/264 | 0/260 | 0/266 | 0/263 | 1/257 |
| PneumoniaInfections and infestations | 0/264 | 0/260 | 0/266 | 0/263 | 1/257 |
| VomitingGastrointestinal disorders | 0/264 | 0/260 | 0/266 | 0/263 | 1/257 |
| Mental DisorderPsychiatric disorders | 0/264 | 1/260 | 0/266 | 0/263 | 0/257 |
| Crohn's DiseaseGastrointestinal disorders | 0/264 | 1/260 | 0/266 | 0/263 | 0/257 |
| IndurationGeneral disorders | 0/264 | 1/260 | 0/266 | 0/263 | 0/257 |
| InjuryInjury, poisoning and procedural complications | 0/264 | 0/260 | 0/266 | 1/263 | 0/257 |
| Drug EruptionSkin and subcutaneous tissue disorders | 0/264 | 0/260 | 0/266 | 1/263 | 0/257 |
| Event | Cellulitis or Larger Abscess - Clindamycin | Cellulitis or Larger Abscess - TMP-SMX | Limited Abscess - Clindamycin | Limited Abscess - TMP-SMX | Limited Abscess - Placebo |
|---|---|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 27/264 | 28/260 | 46/266 | 17/263 | 20/257 |
| AbscessInfections and infestations | 21/264 | 39/260 | 13/266 | 29/263 | 35/257 |
| CellulitisInfections and infestations | 16/264 | 23/260 | 3/266 | 6/263 | 9/257 |
All participants enrolled in the protocol are included in the baseline analysis population.
| Age, Categorical(Participants) | Cellulitis or Larger Abscess - Clindamycin | Cellulitis or Larger Abscess - TMP-SMX | Limited Abscess - Clindamycin | Limited Abscess - TMP-SMX | Limited Abscess - Placebo | Total |
|---|---|---|---|---|---|---|
| <=18 years | 81 | 74 | 101 | 91 | 89 | 436 |
| Between 18 and 65 years | 181 | 184 | 164 | 169 | 166 | 864 |
| >=65 years | 2 | 2 | 1 | 3 | 2 | 10 |
| Age, Continuous(years) | Cellulitis or Larger Abscess - Clindamycin | Cellulitis or Larger Abscess - TMP-SMX | Limited Abscess - Clindamycin | Limited Abscess - TMP-SMX | Limited Abscess - Placebo | Total |
|---|---|---|---|---|---|---|
| Mean | 26.8 ± 17.2 | 27.5 ± 16.9 | 24.8 ± 17.8 | 25.6 ± 18.1 | 26.2 ± 18.7 | 27.1 ± 17.0 |
| Sex: Female, Male(Participants) | Cellulitis or Larger Abscess - Clindamycin | Cellulitis or Larger Abscess - TMP-SMX | Limited Abscess - Clindamycin | Limited Abscess - TMP-SMX | Limited Abscess - Placebo | Total |
|---|---|---|---|---|---|---|
| Female | 129 | 121 | 126 | 111 | 101 | 588 |
| Male | 135 | 139 | 140 | 152 | 156 | 722 |
| Region of Enrollment(participants) | Cellulitis or Larger Abscess - Clindamycin | Cellulitis or Larger Abscess - TMP-SMX | Limited Abscess - Clindamycin | Limited Abscess - TMP-SMX | Limited Abscess - Placebo | Total |
|---|---|---|---|---|---|---|
| United States | 264 | 260 | 266 | 263 | 257 | 1310 |
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National Institute of Allergy and Infectious Diseases (NIAID)